MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRILL STOP FOR 03.037.022; MISC ORTHO SURGICAL INSTR

Catalog Number	03.037.023
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A device history record review was requested.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 intramedullary nailing of a right trochanteric hip fracture, a synthes 6/9mm drill stop slipped off of the 85mm indention of synthes 6/9 stepped drill bit.The surgeon completed the surgery successfully without delay.The patient was reported to be in good condition following the procedure.This is report 1 of 1 for (b)(4).
Event or Problem Description
It was noted the surgery was completed by removing the drill stop and continuing to drill using live fluoroscopy.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Part 03.037.023, lot 9518504: manufacturing location: (b)(4).Release to warehouse date: october 13, 2015.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

• Brand Name: DRILL STOP FOR 03.037.022
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7439778
• Report Number: 2939274-2018-51796
• Device Sequence Number: 1510250
• Product Code: LXH
• UDI-Device Identifier: 10886982070395
• UDI-Public: (01)10886982070395
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 03/28/2018

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: 03.037.023
• Device Lot Number: 9518504
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 05/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 97