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

Model Number 210711

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: according to the information received, it was reported that during the surgery of left shoulder dislocation repair, opened the packing (did not use), noted the anchor was deformed.  the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received and pictures provided by customer.Visual analysis of the returned device and pictures received, confirm that the anchor was bent.A manufacturing record evaluation was performed for the finished device lot number: 3l05872, and no non-conformance's were identified.Based on the information currently available this complaint can be confirmed.A manufacturing investigation activity has been performed to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.There has been a closer look to the packaging processes.The results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the document reviewed.The storage conditions of this device was unknown, and it is possible that was exposed to an elevated temperature before it was opened in the operating room prior to surgery.The elevated temperature and the slight tension on the suture could result in the deformation of the anchor.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.As per ifu-109002, store in a cool dry area.There was no information provided regarding this condition.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of (b)(4) devices that were released to distribution.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications at this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

Event Description

It was reported by the sales rep in (b)(6) that during a shoulder repair procedure on (b)(6) 2021, it was observed that the anchor device was deformed upon opening its package.During in-house engineering evaluation, it was determined that the device was bent.Another like device was used to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: LUPINE BR 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: 11651621
• MDR Text Key: 245085453
• Report Number: 1221934-2021-01178
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001095
• UDI-Public: 10886705001095
• 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: 04/09/2021

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 Model Number: 210711
• Device Catalogue Number: 210711
• Device Lot Number: 3L05872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 04/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2019
• 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