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	12/01/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device was received and inspected.Visual observation confirms the lower jaw bent downward, consistent with the device hitting bone during a procedure or being mishandled/ dropped, an indication of blunt force impact.An expressew iii needle was loaded onto the device and tested on a sample rubber strip.The needle could be deployed with great difficulty.The angle of the deformed lower jaw is also a contributing factor for difficulty in deploying the needle.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 synthes mitek complaints system revealed dissimilar complaints for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode, although one possible root cause would be the device jaw made contact with bone, resulting in the jaw becoming bent.No corrective action is required and no further action is warranted at this time.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.(b)(4).
Event or Problem Description
It was reported by the sales rep that during a rotator cuff repair, it was observed that the jaws on the customer's expressew iii without hook was bent and not firing properly.The surgeon completed the procedure with another like device with no patient consequences or delays.The sales rep had no further information regarding how the device was firing.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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: 7868539
• Report Number: 1221934-2018-50965
• Device Sequence Number: 1679069
• Product Code: LXH
• UDI-Device Identifier: 10886982153821
• UDI-Public: 10886982153821
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 12/01/2015

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
• Device Lot Number: 22548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2015
• Initial Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1