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 2019-04-08 for TOMOFIX OSTEOTOMY CHISEL 20MM WIDTH 397.994 manufactured by Wrights Lane Synthes Usa Products Llc.
[141342937]
A review of the device history records has been requested. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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
[141342938]
It was reported that on (b)(6) 2019, during a corrective osteotomy of a distal femur using a tomofix set,?? The back end of the chisel broke off. The surgeon made the first cut for the osteotomy using a saw blade and then inserted the tomofix osteotomy chisel into the cut. He began hitting the chisel with a mallet attempting to complete the osteotomy and after several blows, the chisel broke. There were no fragments generated form the broken device. There was no surgical delay. Procedure was successfully completed with no patient consequence.?? Concomitant medical products reported: unknown saw blade (part # unknown, lot# unknown, quantity # 1); unknown mallet (part # unknown, lot# unknown, quantity # 1). This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-57375 |
| MDR Report Key | 8493601 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-08 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-03-14 |
| Date Mfgr Received | 2019-04-24 |
| Device Manufacturer Date | 2016-10-26 |
| Date Added to Maude | 2019-04-08 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOMOFIX OSTEOTOMY CHISEL 20MM WIDTH |
| Generic Name | CHISEL, SURGICAL INSTRUMENT |
| Product Code | FZO |
| Date Received | 2019-04-08 |
| Returned To Mfg | 2019-03-28 |
| Model Number | 397.994 |
| Catalog Number | 397.994 |
| Lot Number | L080921 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-08 |