MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-04-20 for STANDARD TPLO JIG FOR USE W/24MM/27MM/30MM SAW GUIDES VQ0001.00 manufactured by Synthes Monument.
[43172429]
G5-510k: device is a veterinary only product. No patient information will be reported. (b)(4). Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[43172430]
This is a veterinary complaint; there was no human patient involvement. It was reported during a tibial plateau leveling osteotomy (tplo) surgery, a set screw broke during removal of the jig. The pin is stuck in the set screw hole. The patient was a (b)(6) bernes mountain dog. The surgery was completed successfully with no patient harm. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[45106556]
Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[46717992]
Additional narrative: device history records was conducted. The report indicates that the dhr review part number: vq0001. 00, synthes lot number: is10062, release to warehouse date: 03-oct-2008 supplier: (b)(4). No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition. Synthes manufacturing location was discovered upon receipt of subject device. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[46765826]
Product investigation summary: one standard tibial plateau leveling osteotomy (tplo) jig (part vq0001. 00 / lot is10062) was received with the complaint category of? Broken: intraoperatively.? The complaint condition is confirmed as the device was received with one of the two wire holding set screws broken. The head of the set screw was not received and due to the broken condition a wire was captured in the jig and could not be removed. The threads of the set screw are retained in the jig. A device history record (dhr) review, visual inspection, functional test, and drawing review were performed as part of this investigation. The root cause could not be definitively determined due to: unknown circumstances at the time of the issue, the screw head not being received, and the unknown use and maintenance over the lifespan of the device. The design was determined to be suitable for the intended use when employed and maintained as recommended. The evaluation shows that this device is part of the standard tibial plateau leveling osteotomy (tplo) system and intended for maintaining alignment during the osteotomy. It is attached to the bone using two 3. 0mm kirshner wires and mates with the desired saw guide. This information is provided per the standard tibial plateau leveling osteotomy (tplo) system technique guide. The device was investigated: surface wear and nicks were observed on the device. Thus, the complaint condition is confirmed and consistent with the reported condition. Replication of the complaint condition is not applicable as the set screw is already broken. A review of the current design drawing for the top level assembly was performed. A design change updated the drawing to allow for use of a longer set screw to reduce the likelihood of screw loss. The relevant component drawings were also reviewed; jig pin screw, jig pin screw- long, end arm, and the end arm for the long screw. During the investigation, no product design issues were observed that would contribute to the complaint condition. The design was determined to be suitable for the intended use when employed and maintained as recommended. The broken screw is consistent with torsional force above the yield limit of the screw. However, the cause of this force, and potential previously accumulated fatigue reducing the force required for breakage, could not be definitively determined due to unknown circumstances at the time of the issue. A replacement screw is available and information on care and maintenance, including the recommendation of inspection after processing, is provided per the processing synthes reusable medical devices? Instruments, instrument trays, and cases. During the investigation, no product design issues were observed that may have contributed to the complaint condition. Corrected dhr information: device history record(s) not available since the returned part was a prototype that was ordered in july, 2008. The documentation supports the fact that the part was manufactured by (b)(4) and was in fact a prototype. Manufacturing date is n/a. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2016-12184 |
| MDR Report Key | 5591233 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-04-20 |
| Date of Report | 2016-04-04 |
| Date of Event | 2016-04-04 |
| Date Mfgr Received | 2016-06-07 |
| Device Manufacturer Date | 2008-10-03 |
| Date Added to Maude | 2016-04-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TERRY CALLAHAN |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1051 SYNTHES AVE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STANDARD TPLO JIG FOR USE W/24MM/27MM/30MM SAW GUIDES |
| Generic Name | TRACTION, COMPONENT, INVASIVE |
| Product Code | JEC |
| Date Received | 2016-04-20 |
| Returned To Mfg | 2016-04-22 |
| Catalog Number | VQ0001.00 |
| Lot Number | IS10062 |
| ID Number | (01)10886982012418(10)IS10062 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | 1051 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-20 |