MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS®/DCS® GUIDE SHAFT WITH FLATS

Catalog Number	338.23
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during a hip surgery on (b)(6) 2018, the surgeon noticed that the guide shaft with flats would not able to firmly insert into the wrench upon completion of the lag screw insertion assembly.The tabs on the guide shaft were bent preventing a full insertion.A 30-minute surgical delay was noted.The procedure was completed successfully.Patient outcome was unknown.No patient consequence reported.Concomitant devices reported: unknown wrench (part # unknown, lot# unknown, quantity #1), unknown lag screw (part # unknown, lot# unknown, quantity #1) this is report 1 of 1 for (b)(4).

• Brand Name: DHS®/DCS® GUIDE SHAFT WITH FLATS
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7650637
• Report Number: 2939274-2018-52681
• Device Sequence Number: 18871274
• Product Code: FZX
• UDI-Device Identifier: 10886982193278
• UDI-Public: (01)10886982193278
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 338.23
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1