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 2016-07-26 for TREPHINE ATTACHMENT 9.5MM DIAMETER 387.660 manufactured by Synthes Usa.
[50464274]
Device was used for treatment, not diagnosis. Additional narrative: (b)(4). Lot unknown. Device is an instrument and is not implanted/explanted. Device is not expected to be returned for manufacturer review/investigation. Subject device has not been received. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. Part/lot combination unknown at synthes (b)(4), no dhr review possible. The lot number is matched to article 314. 030, not 387. 660 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
[50464275]
It was reported that during a procedure on (b)(6) 2016, two items from the bone harvest set broke while retrieving bone graft from left proximal tibia. The trephine broke at the phalanges and the cutting piece of the attachment also broke. Surgeon was able to retrieve the broken fragments which were present in the graft that was collected. Surgeon confirmed that no fragments remained in the patient. There was a 10 minute delay to the procedure and the patient is in stable condition. This complaint involves 2 devices. This report is 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2016-13645 |
| MDR Report Key | 5822216 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-07-26 |
| Date of Report | 2016-07-08 |
| Date of Event | 2016-07-08 |
| Date Mfgr Received | 2016-07-08 |
| Date Added to Maude | 2016-07-26 |
| 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 | TERRY CALLAHAN |
| 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 | TREPHINE ATTACHMENT 9.5MM DIAMETER |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2016-07-26 |
| Catalog Number | 387.660 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-07-26 |