MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-09-28 for 2.0MM MLP BENDER/CUTTER 329.143 manufactured by Synthes Tuttlingen.
[55879478]
Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received. (b)(6). The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the device history records has been requested. 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
[55879479]
Device report from synthes on an event in (b)(6) as follows: (b)(6) reported the following: it was reported that a 2. 0mm mandible locking plate (mlp) bender/cutter was broken. There is no known patient involvement. This complaint has 1 device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[58833605]
Additional narrative: date of event is unknown. Device history records review was completed for part # 329. 143, lot # a7qa43. Manufacturing date: feb 15, 2007. Review of the device history record of (b)(6) 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 4 parts of the lot were checked 100% for ctq features and for function at the final inspection on feb 14, 2007. No non conformance reports were generated during production. The device was received and the product evaluation is in progress. No conclusion can be drawn. 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
[62548451]
A product development investigation was performed for the mandible locking plate bender/cutter (part number 329. 143,, lot number a7qa43). The subject device was returned with the complaint condition stating the device was returned with the movable handle broken off at the cutting slot. The edge of the in-plane bending surface shows significant indents inconsistent with recommended use. The broken section could no longer be moved. Replication of the complaint condition is not applicable as the device is already broken. The complaint condition was confirmed. A device history record (dhr) review, visual inspection, drawing review, complaint history review, and risk assessment review were performed as part of this investigation. Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint. No non-conformances were generated during production. A review of the current design drawing was performed. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. A definitive root cause could not be determined given the unknown circumstance at the time of the issue and over the lifespan of the device. The breakage is the result of force beyond the yield strength of the device. The edge of the in-plane bending surface shows significant indents inconsistent with recommended use. 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 | 9680938-2016-10152 |
| MDR Report Key | 5984843 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-28 |
| Date of Report | 2016-08-29 |
| Date Mfgr Received | 2016-11-21 |
| Device Manufacturer Date | 2007-02-15 |
| Date Added to Maude | 2016-09-28 |
| 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 | 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 | 2.0MM MLP BENDER/CUTTER |
| Generic Name | INSTRUMENT, BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2016-09-28 |
| Returned To Mfg | 2016-10-10 |
| Catalog Number | 329.143 |
| Lot Number | A7QA43 |
| ID Number | (01)10887587039190(10)A7QA43 |
| 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 | 2016-09-28 |