MAUDE Adverse Event Report: DEPUY MITEK LLC US FEMORAL INTRAFIX SHEATH TRIAL 9&10MM -NS; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Catalog Number	254667
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The lot number is not currently available.Without a lot number the device history records review could not be completed.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.It was observed that the handle of the device was broken across the width of the component.It was also observed that the device had numerous striations and nicks on the portion of the device that gets malleted, and the lettering was faded suggesting that the device has been heavily used.It was stated by the mitek sales rep that this breakage occurred intraoperatively when the surgeon malleted the device.The device is reusable.There is no lot number etched on the device, therefore per changes in device identification requirements this attribute suggests that the device is at least 3 years old.Therefore, a potential root cause for the reported failure can be attributed to fair wear and tear from reuse of the device.However, given the information provided we cannot discern a definitive root cause for the reported failure.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 as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the sales rep that during anterior cruciate ligament (acl) reconstruction surgical procedure, it was observed that the handles on the femoral intrafx shth insrtr8mm and femoral intrafix sheath trial 9 &10 mm -ns broke while being malleted at the end of the procedure.The doctor finished the procedure with no patient consequences.It was not reported if there was a delay in the surgical procedure.It was not reported if a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: FEMORAL INTRAFIX SHEATH TRIAL 9&10MM -NS
• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9124960
• Report Number: 1221934-2019-58595
• Device Sequence Number: 16727598
• Product Code: LXH
• UDI-Device Identifier: 10886705013494
• UDI-Public: 10886705013494
• 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: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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: 254667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1