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 2016-10-11 for MATRIXMANDIBLE SMALL PLATE CUTTER 03.503.079 manufactured by Synthes Tuttlingen.
[57097799]
There was no known reported patient involvement associated with the complained event. Date of event: unknown. Device is an instrument and is not implanted/explanted. Review of the device history record of (b)(4) for part number 03. 503. 079 and lot number t930632 showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint. A review of inspection records and certifications, confirm that the components and final product met inspection records. All (b)(4) parts of the lot were checked 100% for ctq features and for function at the final inspection on 17-feb-2008. No non conformance reports were generated during production. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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
[57097800]
It was reported from service and repair department that the synthes evaluation equipment matrix mandible small plate cutter is broken. Issue identified during inspection activities of the evaluation set. There were no issues reported by the customer. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[61327143]
Additional narrative: a product development investigation was performed for the subject device (matrixmandible small plate cutter, part number 03. 503. 079 lot number t930632). The subject device was returned with the complaint condition stating that the device is broken. Issue identified during inspection activities of the evaluation set. There were no issues reported by the customer. This complaint is confirmed. The silicone insert component is missing from the returned 8 year old plate cutter. Etched on the device is "remove silicone insert for cleaning and sterilization". Therefore, the most likely cause for this complaint is that the silicone insert component was removed for sterile processing and subsequently lost. Whether this complaint condition can be replicated at customer quality (cq) is not applicable as the silicone insert is already missing. A visual inspection under 5x magnification, device history record (dhr) review, complaint history review, drawing review, and risk assessment review were performed as part of this investigation. No product design issues or discrepancies were observed. No new, unique or different patient harms were identified as a result of this evaluation. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. The returned instrument (03. 503. 079 matrixmandible small plate cutter) is an instrument used to cut matrix mandible plates 1. 0mm through 1. 5mm thick, to the desired length between the plate holes per the matrix mandible technique guide. Drawing was reviewed during this investigation. No product design issues or discrepancies were observed. 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
| Report Number | 9680938-2016-10156 |
| MDR Report Key | 6016969 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-11 |
| Date of Report | 2016-09-21 |
| Date Mfgr Received | 2016-11-15 |
| Device Manufacturer Date | 2008-02-17 |
| Date Added to Maude | 2016-10-11 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARK VORNHEDER |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MATRIXMANDIBLE SMALL PLATE CUTTER |
| Generic Name | INSTR,BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2016-10-11 |
| Returned To Mfg | 2016-09-21 |
| Catalog Number | 03.503.079 |
| Lot Number | T930632 |
| ID Number | (01)10887587011929(10)T930632 |
| 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 TUTTLINGEN |
| Manufacturer Address | UNTER HASSLEN 5 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-11 |