MAUDE Adverse Event Report: DEPUY MITEK LLC US UNIDENTIFIED DEPUY IMPLANT OR INSTRUMENT; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number UNK PRODUCT

Device Problem Break (1069)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi:(b)(4) - unavailable.Depuy synthes has been informed that the catalog number and lot number is not available.

Event Description

It was reported by the customer via medwatch report that a patient underwent surgery for left shoulder arthroscopic revision rotator cuff repair and subacromial decompression.A metal suture grasper broke well into her shoulder, about 5mm.Radiographs revealed a routine metallic foreign body in the left shoulder posterior subacromial space.Identified three week later and taken to surgery.Foreign body was mobilized and secured with a grasper and removed in its entirety.Medwatch was received via mail by mitek regulatory affairs, then forwarded to depuy mitek quality.

Event Description

Additional information received on 31october2018: the sales representative did not cover the case and was notified sometime after the incident.No further complaint information is known.

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.Evaluation statement: 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 device history record (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.Udi: unavailable.Depuy synthes has been informed that the catalog number and lot number are not available.

• Brand Name: UNIDENTIFIED DEPUY IMPLANT OR INSTRUMENT
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7433472
• MDR Text Key: 105583915
• Report Number: 1221934-2018-50468
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK PRODUCT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2018
• Supplement Dates Manufacturer Received: 10/31/2018
• Supplement Dates FDA Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR