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

Catalog Number 214124

Device Problem Bent (1059)

Patient Problem Tissue Damage (2104)

Event Date 12/29/2017

Event Type  Injury  

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.(b)(4).Incomplete the lot number is currently unavailable.

Event Description

It was scheduled at the (b)(6) with a patient of dr.(b)(6) for rotator cuff repair.The planning was carried out with the specialist and the implants were ready.Once admitted to surgery, the relevant instruments were readied for the procedure.Dr.(b)(6) requested a healix anchor in titanium and when he was going to repair the tissue, the expressew iii clamp was readied, which was observed to be bent at the tip (ref (b)(4)), when assembling the expressew needle it is observed that it does not slide easily and the needle does not come out through the clamp.The doctor has an anchor inside the patient, but he does not have to pass the threads through the tissue.The doctor has to make a mini-open incision to repair the tear; other tweezers and suture pins were given, but the tissue was so retracted that it did not let him approach.After several attempts, the surgeon decides to remove the strands from the anchor and close by planes.Doctor: (b)(6), account: (b)(6), address: (b)(6).Product: needle pin sutura expressew iii code: 214141, lot: 42267.Product: anchor healix titanium 4.5mm code: 222253, lot: l502610.The complaint is being registered late, since the j&j alert date is (b)(6) 2017 but that day and (b)(6) 2018 were national holidays in the country.Therefore, the complaint was only processed on (b)(6) 2018.

Manufacturer Narrative

Subsequent follow-up with the reporter, additional information was received.Reporter clarified that the event happened during surgery.There was an unspecified delay in the surgical procedure.The procedure was completed as alternatives were readily available.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and 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.

• Brand Name: EXPRESSEW III SUTURE PASSER W/ HOOK
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7219852
• MDR Text Key: 98278058
• Report Number: 1221934-2018-50104
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 214124
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/29/2017
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 10/12/2018
• Supplement Dates FDA Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR