MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE BR DS W/ORTHCRD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 210712

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: b)(4).Investigation summary: according to the information provided, it was reported that during the arthroscopic right rotator cuff repair surgery, opened the packing (did not use), noted the anchor was deformed(as the attached photo shows).The complaint device is not being returned, therefore unavailable for a physical evaluation.However a photo was provided.Upon visual inspection of the photo, it could be observed that the anchor is bent, also the sutures are tensioning from the anchor to the handle's groove.The shaft has no structural anomalies.A manufacturing record evaluation was performed for the finished device 7l19094 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection of the photo, this complaint can be confirmed.The possible root cause can be attributed to the conditions of storage of the device.A combination of warmer temperature and tension can lead to a bent anchor.As per ifu 109002: store in a cool dry area.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

Event Description

It was reported by the affiliate in (b)(6) that during an arthroscopic rotator cuff repair procedure of the right shoulder, it was observed that the lupine br ds w/orthcrd device was deformed upon opening its package.During in-house engineering evaluation, it was determined that the anchor was bent in the picture provided by the customer.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

• Brand Name: LUPINE BR DS W/ORTHCRD
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12031796
• MDR Text Key: 257156033
• Report Number: 1221934-2021-01928
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001101
• UDI-Public: 10886705001101
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 210712
• Device Catalogue Number: 210712
• Device Lot Number: 7L19094
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1