MAUDE Adverse Event Report: DEPUY MITEK LLC US VERSALOK DEPLOYMENT GUN; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Catalog Number	214710
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation summary: the complaint device is not being returned, therefore is unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).Depuy synthes has been informed that the lot number is not available.This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
Our affiliate reported when that when trigger was pulled, the gun did not function properly due to a loosened screw.Another product was used to complete the case.There were no adverse consequences to the patient.Affiliate stated procedure time was extended thirty (30) minutes.Please see also medwatch report 1221934-2018-50757.

• Brand Name: VERSALOK DEPLOYMENT GUN
• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7612870
• Report Number: 1221934-2018-51931
• Device Sequence Number: 11333190
• Product Code: LXH
• UDI-Device Identifier: 10886705004416
• UDI-Public: 10886705004416
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/21/2013

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: 214710
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2013
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1