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 Type  malfunction  

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).Investigation summary: according to the information provided, it was reported that during an arthroscopic shoulder stabiliz, when opening the package of a lupine loop rapide anchor w/orthocord ds the anchor was bent, it is defective.The complaint device was returned and evaluated.The visual inspection revealed that the anchor was bent mid-body, confirming this complaint.The anchor remained intact on the distal end of the inserter and the suture was intact within the handle at the proximal end of the inserter as intended.Our results indicate that this batch of product was processed without any incident elated to the reported problem, and therefore there is no internally assignable cause for the reported problem.The storage conditions of these devices are unknown, and it is possible that they were exposed to high temperatures probably during transportation/ storage/ trunk stock resulting in the anchors to bend.This product should be stored in a cool dry place, away from moisture and direct heat per ifu-109002.There was no information provided regarding this condition.A manufacturing record evaluation was performed for the finished device lot number (6l60605), and no non-conformances were identified.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.

Event Description

It was reported by the affiliate in spain that during an arthroscopic shoulder stabilization procedure on an unknown date, it was observed that the lupine br ds w/orthcrd device was bent and defective upon opening its package.During in-house engineering evaluation, it was determined that the device was bent mid-body.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was 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): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 11080294
• MDR Text Key: 224758367
• Report Number: 1221934-2020-04023
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001101
• UDI-Public: 10886705001101
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2020

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: 12/31/2022
• Device Model Number: 210712
• Device Catalogue Number: 210712
• Device Lot Number: 6L60605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2020
• 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