MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRILL SLEEVE FOR 2.8MM DRILL BIT; GUIDE

Catalog Number	03.120.040
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided for reporting.Date of event is unknown.Device is an instrument and is not implanted/explanted.Device history records (dhr) review was completed for part# 03.120.040, lot# 8379729.Manufacturing location: (b)(6), manufacturing date: apr 23, 2013.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation was completed.As per the technique guide, the returned drill sleeve is a reusable instrument included in the 3.5mm locking attachment plate system for treatment of peri-prosthetic fractures.Visual inspection under 5x magnification at customer quality (cq) revealed post manufacturing damage in the form of nicks/dings on the two distal most thread forms which could impair function.Replication of the complaint/functional test was not possible as the mating device(s) were not returned.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Drawings were reviewed during this investigation.No product design issues or discrepancies were observed.A dimensional inspection on the returned 4+ year old reusable instrument was not performed at cq because the post manufacturing damage was visually confirmed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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
(b)(6) reported following: it was discovered during an unknown femur treatment surgery on an unknown date that the distal threads of a drill sleeve were damaged.There was no reported surgical delay and the surgery could be completed using another available drill sleeve.The patient was reported to be in good standing following the procedure.Concomitant devices reported: drill bit (part # unknown, lot # unknown, quantity 1).This report is for one (1) drill sleeve for 2.8mm drill bit.This is report 1 of 1 for (b)(4).

• Brand Name: DRILL SLEEVE FOR 2.8MM DRILL BIT
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7269886
• Report Number: 2939274-2018-50624
• Device Sequence Number: 2248901
• Product Code: FZX
• UDI-Device Identifier: 10886982074287
• UDI-Public: (01)10886982074287(10)8379729
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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: 03.120.040
• Device Lot Number: 8379729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Initial Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1