MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOINTRAFIX SHEATHTRIAL 9MM *EA; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Catalog Number	254651
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint device was received.Visual observation confirms that the weld is broken between the handle and shaft; causing the shaft to separate from the handle.This complaint can be confirmed.These are reusable devices and the laser etching are faded out.The surface has nicks and minor scratches indicating the possible heavy usage.It is possible that this failure occurred due to repetitive use and sterilization or that the device was dropped on hard surface causing the weld to fail.The device was manufactured prior to lot numbers being assigned and marked on the device, which precludes conducting a batch history review or a lot specific search in the complaints handling system.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 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.(b)(4).Depuy synthes has been informed that the lot number is not available.
Event or Problem Description
It was reported by the sales rep that the customer's bio intrafix sheath broke at the shaft while using the mallet on it during an acl procedure.The case was completed by removing the instrument and using another like device.There were no patient consequences or delays.The sales rep was not present during the case and could not provide any more details.The device is being returned.

• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7486488
• Report Number: 1221934-2018-50559
• Device Sequence Number: 13882254
• Product Code: LXH
• UDI-Device Identifier: 10886705013425
• UDI-Public: 10886705013425
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2018

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: 254651
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Initial Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1