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 2016-10-07 for SHARP HOOK 319.39 manufactured by Synthes Usa.
[56917061]
(b)(4). Device is an instrument and is not implanted/explanted. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. Without a lot number the device history records review could not be completed. 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
[56917062]
It was reported that a sharp hook broke intra-operatively. On (b)(6), 2016 a patient underwent an open reduction internal fixation to repair a right fractured fibula. As the surgeon began to clean the fracture with the device, an approximate eight to ten millimeter piece of the hook broke off from the curvature of the hook and fell into the fracture area. There was a two minute surgical delay as the broken piece was removed intact from the patient. No fragments were reported. A comparable device was used to clean the fracture. The procedure was successfully completed. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[61516730]
A product development investigation was performed for the subject device (sharp hook, part number 319. 39). The subject device was returned with the complaint condition stating that an approximately 8-10 mm portion of the tip of the hook broke off intraoperatively. There was an approximately 2 minute surgical delay as the broken portion was retrieved. The complaint was able to be confirmed at customer quality as the instrument was received with a portion of the hook tip broken off. The break is located approximately 138 mm from the proximal end of the device and the approximately 12 mm distal tip was returned. A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation. 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. Product drawing was reviewed during the investigation. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. A device history review could not be performed as the lot number is unknown. Replication of the complaint is not applicable as the device was received broken. 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 | 2520274-2016-14828 |
| MDR Report Key | 6011523 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-07 |
| Date of Report | 2016-09-19 |
| Date of Event | 2016-09-19 |
| Date Mfgr Received | 2016-11-15 |
| Date Added to Maude | 2016-10-07 |
| 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 |
| 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 | 2016-10-07 |
| Returned To Mfg | 2016-09-27 |
| Catalog Number | 319.39 |
| 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 USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-07 |