MAUDE Adverse Event Report: DEPUY MITEK LLC US INTRAFIX FAMILY SHEATH INSERTER; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Catalog Number	254618
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2018
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.(b)(4).The lot number is not currently available.
Event or Problem Description
It was reported that during an acl procedure, whilst putting in the tibial fixation during an acl the end of the inverter snapped off and was retained in the patient.To remove that, they had to deconstruct the whole structure, and effectively start again.They had a second handle to impact the tibia, but needed to take both femoral and tibial intrafix implants out and replace with new implants.There was a 45 minute delay to procedure.No ae to patient.According to the hospital, the patient outcome post surgery was fine.
Event or Problem Description
It was reported that during an acl procedure, whilst putting in the tibial fixation during an acl the end of the inverter snapped off and was retained in the patient.To remove that, they had to deconstruct the whole structure, and effectively start again.They had a second handle to impact the tibia, but needed to take both femoral and tibial intrafix implants out and replace with new implants.There was a 45 minute delay to procedure.No ae to patient.According to the hospital, the patient outcome post surgery was fine.Additional information provided by the jjm rep via email dated 27 may 2018: the construct had to be taken apart because when the handle broke, they had to start the process again as they had to pull the graft to release the tibia, therefore they had to replace the femoral and tibial intrafix.All available information have been provided.No further information is available.
Additional Manufacturer Narrative
Udi: (b)(4).The lot number is not currently available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device was received and evaluated.The distal tip of the inserter is broken, confirming this complaint.The broken fragment was not returned for evaluation.Scratch marks and deep grooves were discovered on the handle indicating heavy use in the field.This type of failure can be attributed to excessive downforce pressure on the device coupled with off access levering or device mishandling.Other than the possible root causes listed, a specific root cause cannot be determined.Furthermore, no lot number was supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point in time, 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).The lot number is not currently available.

• Brand Name: INTRAFIX FAMILY SHEATH INSERTER
• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7486300
• Report Number: 1221934-2018-50560
• Device Sequence Number: 1125022
• Product Code: LXH
• UDI-Device Identifier: 10886705013166
• UDI-Public: 10886705013166
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup,Followup
• Report Date (Section B): 04/09/2018

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: 254618
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 05/27/2018; 06/21/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 06/14/2018; 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1