MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 5.5MM W/3UB-WHT BL &BLK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202600
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during a rotator cuff repair procedure, the surgeon used an s+n 3.8mm disposable awl to prepare a bone hole in order to repair the patient's rotator cuff tendon, then while the "5.5mm twinfix ultra pk anchor" was being inserted, it cracked on the distal part and it was successfully removed by the surgeon using tweezers.No pieces of shrapnel were left inside the patient.The procedure was successfully completed without delay using a back-up device.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed the device was returned outside of original packaging.The anchor was returned fractured with half hanging from the distal tip and the other half attached to the shaft as intended.The device has not been actuated due to fractured anchor.Based on the condition of the product material found during visual inspection it was determined additional material testing is not required.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A review of the raw material found a material certificate of analysis is required.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force or torsion during implantation.No containment or corrective actions are recommended at this time.

• Brand Name: TWINFIX ULTRA PK 5.5MM W/3UB-WHT BL &BLK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11536936
• Report Number: 1219602-2021-00576
• Device Sequence Number: 17100718
• Product Code: MBI
• UDI-Device Identifier: 03596010647481
• UDI-Public: 03596010647481
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2023
• Device Model Number: 72202600
• Device Catalogue Number: 72202600
• Device Lot Number: 2024811
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 03/21/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention