MAUDE Adverse Event Report: DEPUY MITEK LLC US MENISCAL R/S APPLIER *EA; ORTHOPAEDIC CERCLAGE APPLIER

Catalog Number	228000
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2013
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.Investigation summary: 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.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
The sales rep reported the customer's meniscal applier would not deploy their rapidloc 12 degree needle far enough into the meniscus during a meniscal repair.This caused the anchor to jam in the device and not deploy correctly.The surgeon could no longer pull the trigger for the applier once this happened.He used a different method to complete the procedure and there was a 10 minute delay.The complaint devices were already discarded by the customer.The sales rep stated it was a (b)(4) year old female with preexisting medical conditions.No further information could be provided.

• Common Device Name: ORTHOPAEDIC CERCLAGE APPLIER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8351029
• Report Number: 1221934-2019-56426
• Device Sequence Number: 183261
• Product Code: GEF
• UDI-Device Identifier: 10886705009930
• UDI-Public: 10886705009930
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/11/2013

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: 02/01/2016
• Device Catalogue Number: 228000
• Device Lot Number: 3504583
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2013
• Initial Report FDA Received Date: 02/19/2019
• Patient Sequence Number: 1