MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-01-09 for TREPHINE ATTACHMENT 8.5MM DIAMETER 387.659 manufactured by Synthes Usa.
[5127480]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during retrieval of bone graft from an anterior lumbar interbody fusion (alif) procedure, the trephine instrument broke into 4 pieces. The metal fragments were in the patient? S pelvis, but successfully removed. A surgical delay of 15 minutes was reported. No patient harm was noted. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12745953]
Device is an instrument and is not implanted/explanted. Per facility, fragments were disposed of and instrument will not be returned for review/investigation. Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided. 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
| Report Number | 2520274-2015-10200 |
| MDR Report Key | 4402375 |
| Report Source | 01,05,07 |
| Date Received | 2015-01-09 |
| Date of Report | 2014-12-15 |
| Date of Event | 2014-12-15 |
| Date Mfgr Received | 2014-12-15 |
| Date Added to Maude | 2015-01-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES USA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TREPHINE ATTACHMENT 8.5MM DIAMETER |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2015-01-09 |
| Catalog Number | 387.659 |
| 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 | 2015-01-09 |