MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW III W/O HOOK; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number	214140
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2016
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 device was received and inspected.Visual observations revealed the jaw pin was protruding out of its space contributing to the jaw failure and misalignment of the jaws.The damage to the jaw pin would result in needle deployment issues, confirming this complaint.Clamping excessive tissue between the jaws combined with repetitive twisting action exerts excess side load on the jaw pin resulting in the jaw pin shearing off from its space.This failure can be attributed to user technique.A batch record review has been conducted and 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 synthes mitek complaints system revealed one other dissimilar complaint for this lot of devices that were released to distribution.Based on the overall complaint rate and customer impact, at this point in time, no further action is warranted.However, 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.This report is being filed from the (b)(4) complaint management system as required under mitek¿s corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
The sales representative reported that during a rotator cuff repair that the customer's expressew iii without hook was not firing the needle correctly.The sales representative reported that the end of the device was slightly bent.The surgeon completed the procedure with another like device with no patient consequences.There was a ten (10) minute delay reported.

• Brand Name: EXPRESSEW III W/O HOOK
• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8023647
• Report Number: 1221934-2018-51282
• Device Sequence Number: 13798348
• Product Code: LXH
• UDI-Device Identifier: 10886982153821
• UDI-Public: 10886982153821
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 02/17/2016

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 Catalogue Number: 214140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2016
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1