MAUDE Adverse Event Report: DEPUY MITEK LLC US INTRAFIX TIBIALSHEATH 30MM *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	254601
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint screw and sheath were received and inspected.The screw was partially seated inside the sheath, and there is some tissue debris indicating the screw and sheath were implanted.The returned sheath was examined for any anomaly that could has resulted in the reported failure, and none was found.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.It was reported that the graft size was 8mm, and for 8mm graft it is recommended to use screw size 7-9 and not screw size 8-10.Other than this hypothesis, a root cause for the user to have experienced this failure cannot be determined.No nonconformances were identified for this part-lot number combination per qlik query executed 11/20/2018.At this point in time, no further action is warranted.If additional information is made available to mitek complaints in future, this complaint will be re-opened and re-evaluated.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.No nonconformances were identified for this part-lot number combination per qlik query executed 11/20/2018.Review conducted per nr-0108348.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.(b)(4).
Event or Problem Description
It was reported that the customer's intrafix tibial sheath 30mm and intrafix peek taper screw 8-10mm x 30mm failed during an acl procedure due to the screw bottoming out while using the sheath.Sheath would not guide the screw and allow it to be put in place.The case was completed using another like device.There were no adverse patient consequences.There was a two minute time delay to get the other devices.This is report 1 of 2.

• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8285877
• Report Number: 1221934-2019-56221
• Device Sequence Number: 2463991
• Product Code: MAI
• UDI-Device Identifier: 10886705013074
• UDI-Public: 10886705013074
• Combination Product (Y/N): N
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 254601
• Device Lot Number: 3873238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2016
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1