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 2018-02-02 for HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE 399.68 manufactured by Wrights Lane: Synthes Usa Products Llc.
[98863966]
Device is an instrument and is not implanted/explanted. Device is not expected to be returned for manufacturer review/investigation. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review could not be completed without lot number. 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
[98863967]
It was reported that on (b)(6) 2018, patient underwent a hardware removal/revision procedure for total knee arthroplasty (retrograde nail with 4 interlocking screws and endcap). Upon locating the hardware, it was discovered that all of the screw head recess were stripped and screwdrivers were unsuccessful for removal. Osteotomes, curettes, and gouges were used to loosen bone growth around hardware and a locking plier and vice grip were used to remove three (3) of the screws. During this process, a synthes gouge broke and portion of the device may have been retained in the patient. Intra-operative radiography was unable to determine location of the piece. Secondarily, the most distal screw was unable to be removed and the surgeon decide to abort the planed procedure. The remainder of the hardware which includes the retrograde nail and most distal interlocking screw were removed without incident during another procedure and another facility. This complaint captures intra-operative breakage of gauge. Pc- 000110817 captures the removal of hardware (three screws). Concomitant devices reported: retrograde nail (part#: unknown, lot #: unknown, qty: 1) interlocking screws (part #: unknown, lot #: unknown, qty: 4) endcap (part #: unknown, lot #: unknown, qty: unknown) osteotomes (part #: unknown, lot #: unknown, qty: unknown) curettes (part #: unknown, lot #: unknown, qty: unknown) this report is for one (1) hollow gouge for broken screw exposure. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-50473 |
| MDR Report Key | 7236983 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-02 |
| Date of Report | 2018-01-09 |
| Date of Event | 2018-01-08 |
| Date Mfgr Received | 2018-01-09 |
| Date Added to Maude | 2018-02-02 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE |
| Generic Name | GOUGE,SURGICAL,GEN & PLASTIC SURGERY |
| Product Code | GDH |
| Date Received | 2018-02-02 |
| Catalog Number | 399.68 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Required No Informationntervention | 2018-02-02 |