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

Catalog Number	254618
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.The complaint device was received and inspected.Visual observation confirms that one of the four wings of the distal tip is broken off.Additionally, another one of the four wings was bent in the middle.This failure indicates excess abuse of the device and can be attributed to user technique issue.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.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.Udi: (b)(4).
Event or Problem Description
The sales rep reported that during an unknown procedure on an unknown date the piece of metal at the distal end of their intrafix family sheath inserter broke off and are unable to use the device.The sales rep stated that the device did not break in the patient and that the device broke before being used on the patient.The sales rep reported that the surgeon completed the procedure with another like device with no patient consequences or delays.The sales rep could not provide a lot number for the device but stated that the device is over a year old and has seen heavy use in the field.The sales rep was not present for the case therefore could not provide any further information.The device will be returning for evaluation.

• 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: 8281269
• Report Number: 1221934-2019-56146
• Device Sequence Number: 19368384
• Product Code: LXH
• UDI-Device Identifier: 10886705013166
• UDI-Public: 10886705013166
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2016
• Initial Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1