MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE; GOUGE,SURGICAL,GEN & PLASTIC SURGERY

Catalog Number	399.68
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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).

• Brand Name: HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE
• Common Device Name: GOUGE,SURGICAL,GEN & PLASTIC SURGERY
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7236983
• Report Number: 2939274-2018-50473
• Device Sequence Number: 13487790
• Product Code: GDH
• UDI-Device Identifier: 10886982203038
• UDI-Public: (01)10886982203038(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 399.68
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 104