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

Catalog Number	254601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2014
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.Evaluation statement: the complaint screw and sheath were received and evaluated.Visual inspection reveals the sheath is twisted and broken in multiple locations.The complaint can be confirmed.The reported complaint mentioned that the sheath was probably not fully seated and the bone quality was hard.This is the root cause for this failure, as not fixing the sheath properly, in hard bone, would result in the twisting action, once the screw in inserted.A batch record review has been conducted and the results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.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 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).This report is being filed from the remetrex complaint management system 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 our affiliate that the surgeon went to use an intrafix tibial sheath and it has twisted and broke while he was using it.

• Brand Name: 30MM INTRAFIX TIBIAL SHEATH
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7696129
• Report Number: 1221934-2018-52970
• Device Sequence Number: 658443
• Product Code: MAI
• UDI-Device Identifier: 10886705013074
• UDI-Public: 10886705013074
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2014

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 Expiration Date: 08/01/2016
• Device Catalogue Number: 254601
• Device Lot Number: 3724824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2014
• Initial Report FDA Received Date: 07/17/2018
• Patient Sequence Number: 1