MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-02-21 for IN SITU BENDER-RIGHT 388.112 manufactured by Synthes Monument.
[67928575]
Patient height reported as (b)(6). (b)(4). Device is an instrument and is not implanted/explanted. A device history record review was performed on part # 388. 112, serial/supplier lot # (b)(6), synthes lot # 4898334: release to warehouse date: (b)(6) 2004, supplier: (b)(6). No non-conformance reports (ncr's) were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. He product that would contribute to this complaint condition. 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
[67928576]
It was reported that on (b)(6) 2017, during an initial thoracolumbar spinal fusion surgery, the tip of the in situ bender-right broke off. While putting in a 6. 0mm hex-end rod 500mm, the surgeon used a pair of in situ benders from the uss system to bend the rod in situ. While doing this, the tip of one of the benders broke off. The piece was easily retrieved from the patient. There was no delay in the case and no harm to the patient. Concomitant devices reported: 6. 0mm hex-end rod 500mm (part # 09. 633. 501, lot # unknown, quantity # 1). This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[73360737]
Device was used for treatment, not diagnosis a product investigation was performed. It was reported that during a thoracolumbar spinal fusion, the tip of the in situ bender-right broke off. While putting in a 6. 0mm hex-end rod 500mm, the surgeon used a pair of in situ benders from the uss system to bend the rod in situ. While doing this, the tip of one of the benders broke off. The piece was easily retrieved from the patient. There was no delay in the case and no harm to the patient. The returned device was confirmed to have a broken tip on the non-bent side. In addition, the recesses of both the 'bent' and 'non-bent' sides were found to be worn and deformed. The device has a great deal of surface wear which does not impact functionality. No ncr's were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. A visual inspection, drawing review and dhr review were performed as part of this investigation. The complaint is confirmed. Replication of the complaint condition is not applicable as the device is already broken. No definitive root cause was able to be determined. The device is over 12 years old and shows signs of significant use. The device likely became weakened over many uses and eventually broke. 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 | 1719045-2017-10128 |
| MDR Report Key | 6347641 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-02-21 |
| Date of Report | 2017-01-26 |
| Date of Event | 2017-01-26 |
| Date Mfgr Received | 2017-03-23 |
| Device Manufacturer Date | 2004-12-10 |
| Date Added to Maude | 2017-02-21 |
| 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 | MICHAEL COTE |
| 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 | IN SITU BENDER-RIGHT |
| Generic Name | INSTR,BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2017-02-21 |
| Returned To Mfg | 2017-02-01 |
| Catalog Number | 388.112 |
| Lot Number | 35481 |
| 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 | 2017-02-21 |