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

Catalog Number	254601
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) 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 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 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 of any kind for this lot of 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.(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 the sales representative that during an acl repair that the customer's intrafix screw and two of their intrafix tibial sheaths, 30mm, broke or deformed during insertion.The sales representative reported that the surgeon prepared the bonehole, used the trial, and inserted the first sheath.When he inserted the screw into the sheath, the sheath cracked in half.The surgeon completely removed the screw and broken sheath and re-trialed the bone hole.He then inserted the 2nd sheath and upon inserting the original screw into this sheath it deformed and appeared melted.The surgeon completely removed the sheath and the screw a second time.The surgeon completed the procedure with another type of fixation with no patient consequences but with a 15 minute delay.The customer discarded all of the complaint devices.
Additional Manufacturer Narrative
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 conc lusion 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.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 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 of any kind for this lot of 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.The batch review showed that the devices were conformed to in process and finished goods specifications when released to stock the 6 mar.2014.Expiration date: 2017-01.No nc was opened.(b)(4).This complaint was inadvertently incorrectly reported as a serious injury.This complaint is a part of mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.This will be reported as a malfunction.

• Brand Name: INTRAFIX TIBIAL SHEATH, 30 MM
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• MDR Report Key: 7711398
• Report Number: 1221934-2018-54148
• Device Sequence Number: 19174809
• Product Code: MAI
• UDI-Device Identifier: 10886705013074
• UDI-Public: 10886705013074
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 06/03/2014

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: 01/31/2017
• Device Catalogue Number: 254601
• Device Lot Number: 3754646
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2014
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1