MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA 5.5MM W/2 UB (BLK & BLUE); FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202896
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a shoulder arthroscopy, the twinfix ultra broke inside the patient.The broken piece was retrieved from the patient.The procedure was successfully completed with significant delay using a competitor device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that during a shoulder arthroscopy, the twinfix ultra broke inside the patient.The broken piece was retrieved from the patient using suction.The procedure was successfully completed with significant delay using a competitor device.No other complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history 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 a repeat event.A review of risk management files found that the reported failure was documented appropriately.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.A review of the instructions for use found: use of excessive force during insertion can cause failure of the suture anchor or insertion device.A two-finger technique should be used to insert the anchor.Bone quality must be adequate to allow proper placement of suture anchor.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: TWINFIX ULTRA 5.5MM W/2 UB (BLK & BLUE)
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10708360
• Report Number: 1219602-2020-01622
• Device Sequence Number: 11510280
• Product Code: MBI
• UDI-Device Identifier: 03596010652270
• UDI-Public: 03596010652270
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2021

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: 01/12/2024
• Device Model Number: 72202896
• Device Catalogue Number: 72202896
• Device Lot Number: 2025278
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 10/21/2020; 01/22/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 10/26/2020; 01/26/2021
• 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