MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-08-11 for SHARP HOOK 319.39 manufactured by Synthes Tuttlingen.
[51832998]
Device is an instrument and is not implanted/explanted. Manufacturing date: december 02, 2014. 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. A review of inspection records and certifications, confirm that the, material, components and final product met inspection records, certification. All parts of the lot were checked 100% for features and for function at the final inspection. 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
[51832999]
It was reported that during a routine inspection it was discovered that a dental pick tip was broken. There was no patient or case involvement. This is report 1 of 1 for com-(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[55600829]
A product investigation was completed: one sharp hook (part number 319. 39, lot number t115586) was received. A device history record (dhr) review, visual inspection, drawing review, complaint history review, and risk assessment review were performed as part of this investigation. The complaint condition is confirmed as the sharp hook was received with the distal tip broken. The break is located approximately 135mm from the proximal end of the device and the distal portion was not received. Near the break the shaft shows slight off axis bending. The balance of the device shows wear consistent with use and is in functional condition. The received condition is indicative of having been subjected to force beyond the yield strength of the device. However, the root cause could not be definitively determined as the method of use and maintenance and the conditions at the time of the damage are unknown. The returned part was determined to be suitable for the intended use when employed and maintained as recommended and the risk assessment was found to adequately address the complaint condition. Per the technique guide, the sharp hook (319. 39) is used across various procedures. This device is intended for several applications such as repositioning fragments, checking alignment of fracture ends, and removing ingrown tissue from screw heads. A review of the current design drawing / manufactured revision 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. The received condition is indicative of having been subjected to force beyond the yield strength of the device. However, the root cause could not be definitively determined as the method of use and maintenance and the conditions at the time of the damage are unknown. During the investigation no product design issues or discrepancies were observed that may have contributed to the 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
| Report Number | 9680938-2016-10123 |
| MDR Report Key | 5868069 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-08-11 |
| Date of Report | 2016-07-24 |
| Date Mfgr Received | 2016-09-15 |
| Device Manufacturer Date | 2014-12-02 |
| Date Added to Maude | 2016-08-11 |
| 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 |
| 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 | SHARP HOOK |
| Generic Name | HOOK, SURGICAL, GEN & PLASTIC SURGERY |
| Product Code | GDG |
| Date Received | 2016-08-11 |
| Returned To Mfg | 2016-08-03 |
| Catalog Number | 319.39 |
| Lot Number | T115586 |
| ID Number | (01)10886982190253(10)T115586 |
| 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 | 2016-08-11 |