MAUDE Adverse Event Report: DEPUY MITEK LLC US INTRAFIXFAMILY TIBIAL SHEATHINSERTER; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Catalog Number	254618
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: (b)(4).The complaint device was received and evaluated.Visual observation confirmed that the distal tip was broken off.The root cause for this failure can associated with excessive force applied to the device during use.Other than this, a definitive root cause could not be determined as no lot/batch information was provided and reported information was limited.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point, no corrective action is required and no further action is warranted.However, depuy synthes 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) - incomplete.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.Associated medwatch: 1221934-2018-52025.
Event or Problem Description
It was reported by the sales rep that during an acl procedure both the customer's intrafix sheath inserter and femoral sheath inserter broke at the handle in this case while being malleted.The sales rep was not present at the case, and there were no reported patient consequences.They swapped the devices with other like devices to complete the procedure.

• Brand Name: INTRAFIXFAMILY TIBIAL SHEATHINSERTER
• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7775615
• Report Number: 1221934-2018-52022
• Device Sequence Number: 19280938
• Product Code: LXH
• UDI-Device Identifier: 10886705013166
• UDI-Public: 10886705013166
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2016

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: 254618
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2016
• Initial Report FDA Received Date: 08/11/2018
• Patient Sequence Number: 1