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 2016-05-26 for TREPHINE ATTACHMENT 7.0MM DIAMETER 03.111.026 manufactured by Synthes Usa.
[46032849]
Device was used for treatment, not diagnosis. Patient initials, dob & weight not provided for reporting. (b)(4). Device is an instrument and is not implanted/explanted. Device is not expected to be returned for manufacturer review/investigation. (b)(4). 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 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
[46032850]
It was reported that during foot fusion surgery the cutting chip of the trephine attachment 7. 0mm diameter broke in multiple pieces in a patient's tibia on (b)(6) 2016. All the fragments were retrieved. Additional x-rays were taken and it was confirmed that no piece of instrument remained in the patient. Spare device was available to complete the procedure. Reportedly there was surgical delay of 10 minutes. Surgery was completed successfully. This complaint involves 1 device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2016-12886 |
| MDR Report Key | 5682752 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-26 |
| Date of Report | 2016-05-12 |
| Date of Event | 2016-05-12 |
| Date Mfgr Received | 2016-05-12 |
| Date Added to Maude | 2016-05-26 |
| 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 7.0MM DIAMETER |
| Generic Name | TREPHINE ATTACHMENT 7.0MM DIAMETER |
| Product Code | HWK |
| Date Received | 2016-05-26 |
| Catalog Number | 03.111.026 |
| 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 | 1. Required No Informationntervention | 2016-05-26 |