MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202595

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/12/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a shoulder rotator cuff repair, the twinfix ultra pk sterilization package was found damaged before opening.The procedure was completed with a backup device with no delay nor patient injury.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10, h3,h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images revealed that the device packaging had already been opened and the device had been taken out.It could not be determined if the opening occurred at the customer site or prior to arrival.A visual inspection revealed that the device had already been opened.The seals that had not yet been opened were inspected and found to meet standards.The ones that had been peeled away already had all appropriate markings for seals and no indications of failure.There were no cuts or improper pouch openings.There was some debris and fibers within the bag and on the handle, likely due to the device being opened.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.The complaint was confirmed, but the root cause could not be established, as investigation could not determine whether the opening occurred at the customer site or prior to arrival.

• Brand Name: TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11614561
• MDR Text Key: 244871796
• Report Number: 1219602-2021-00767
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010647467
• UDI-Public: 03596010647467
• Combination Product (y/n): N
• PMA/PMN Number: K093228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2023
• Device Model Number: 72202595
• Device Catalogue Number: 72202595
• Device Lot Number: 2023176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 68