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

Catalog Number	254618
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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).Lot number unavailable.
Event or Problem Description
It was reported that the head of sheath inserter broke off from the shaft of the inserter while inserting the tibial sheath implant into the tibial tunnel.The fragment remained in the tunnel, and had to be removed by the surgeon before the screw could be inserter.Action were taken to manage the problem during the procedure.The instrument inserted the sheath, so once the broken fragment was retrieved, the case was normal: there was a 5 minute delay to procedure.There were no adverse events to the patient.The patient outcome post surgery was good.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 evaluation statement: the device has not been returned to mitek for evaluation, therefore this complaint cannot be confirmed.Furthermore, no lot number was supplied which precludes conducting a device history record review or a lot specific search in the depuy synthes mitek complaints handling system.The root cause for the reported failure cannot be determined.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.Should the complaint device ever be received at some point in time in the future, this complaint file will be reopened at that time, and an evaluation will be performed and documented.Udi:(b)(4).The lot number is not currently available.
Event or Problem Description
Additional information received on 06september2018: it was noted the tunnel and graft size was unknown but the that the tunnel would have been prepared as per the technique (drilled as per graft size, and trialed prior to shaye insertion).Trialing was performed.The procedure was completed with the head of the instrument that broke off being removed, and screw inserted.None that we are aware.There were no procedural or patient anatomy factors which may have contributed to the breakage.

• 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: 7803264
• Report Number: 1221934-2018-54526
• Device Sequence Number: 2488941
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2018

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?: No
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 10/24/2018
• Patient Sequence Number: 1