MAUDE Adverse Event Report: DEPUY MITEK LLC US INTRAFIX TIBSHEATHINSERT FIXHNDLE *EA; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Catalog Number 254616

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2013

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device was received and evaluated.Visual inspection confirms the distal tip is completely broken off.The returned broken pieces were examined and can be concluded that no pieces are missing.All broken pieces were returned.The storage/ cleaning details of this device is unknown and therefore a root cause cannot be determined.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 in time, 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.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 Description

It was reported that upon return of a loaner kit, the tip of one (1) intrafix tibial sheath inserter, fixed handle was found broken.This case has been reported by the loan kit technician during loan kit inspection.The instrument had further been assessed by depuy engineering.No further information can be obtained as the case was not reported by a customer.

• Type of Device: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7813767
• MDR Text Key: 118260961
• Report Number: 1221934-2018-51354
• Device Sequence Number: 1
• Product Code: GEF
• UDI-Device Identifier: 10886705013142
• UDI-Public: 10886705013142
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254616
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2014
• Date Manufacturer Received: 07/27/2013
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1