MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNISPAN MENISCAL REPAIR 27DEG; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228142

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: according to the information provided, it was reported that during the surgery of meniscus repair, opened the packing(did not use), noted the needle was deformed (as the photo shows).Another device was used to complete the surgery.The complaint device was received and evaluated, on visual inspection it could be observed that the needle is bent in the middle section, also, the plates and sutures were not returned.There is a damage to the silicon sleeve that holds the plates and sutures.Upon reviewing the photo provided by the customer, the package of the device is damaged, which is a sign of a transportation and storage issue.A manufacturing record evaluation was performed for the finished device 6l68229 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 result, this complaint can be confirmed.Considering that the plates and sutures were not returned, and the silicon sleeve is damaged, a possible root cause can be attributed to a mishandling of the operator at the moment of unpackaging however this cannot be conclusively determined.The root cause for the packaging damaged can be attributed to transportation and storage.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 a meniscal repair procedure on (b)(6) 2021, it was observed that the omnispan meniscal repair 27degree needle device was deformed upon opening its package.During in-house engineering evaluation, it was determined that the needle was bent in the middle section.Another like device was used to complete the procedure without a reported delay.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: OMNISPAN MENISCAL REPAIR 27DEG
• 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: 11445092
• MDR Text Key: 238687509
• Report Number: 1221934-2021-00756
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705010042
• UDI-Public: 10886705010042
• 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: 02/25/2021

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: 12/31/2022
• Device Model Number: 228142
• Device Catalogue Number: 228142
• Device Lot Number: 6L68229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1