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

Catalog Number	254601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.The batch review 3689948 showed that the devices were conformed to in process and finished goods specifications when released to stock the 13 may 2013.Expiration date: 2016-03 (according to retained labels).Nc was opened relating to deals with a deviation occurred on the sterilization parameters with no functional impact on the finished goods, with no link with this complaint.Evaluation statement : the complaint device is not being returned, therefore is unavailable for a physical evaluation.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed with an unrelated (non-conformance / out of tolerance) to the reported 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 of any kind for this lot of 398 devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The sales rep reported while the surgeon was inserting one of his intrafix peek screws into the intrafix tibial sheath that was already inserted, a portion of the distal tip of the screw broke and damaged the sheath inside during an acl procedure.The surgeon removed both the broken screw and all its fragments and the sheath.He then inserted a new sheath and a new screw with no issues.There were no patient consequences and a 5 minute delay.Both devices were discarded already by the customer.The sales rep was no present but was able to provide the following information.The surgeon used an 8 and a 1/2 tunnel, the graft was also 8 and a 1/2.It was an 8-10x 30 mm size screw and he stated this surgeon does not use a tensioner.He was unaware if the sheath was antirotation tab placed at the 3 or 9 oclock position.It was a (b)(6) male patient with hard bone.Please see also medwatch report 1221934-2018-51184.

• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7686449
• Report Number: 1221934-2018-51183
• Device Sequence Number: 11112260
• Product Code: MAI
• UDI-Device Identifier: 10886705013074
• UDI-Public: 10886705013074
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2013

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: 03/31/2016
• Device Catalogue Number: 254601
• Device Lot Number: 3689948
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2013
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR