MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA 4.5MM W/2 UB (BLK &BLUE); FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202894
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff repair, the anchor of the twinfix ultra came out.The procedure was successfully completed without delay using a back-up device.An additional bone hole was performed in order to place the back-up device.No patient injury or other 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
H3, h6: the reported 4.5 twinfix ultra pk anchor assembly, used in treatment, has been returned for evaluation.Only the inserter was returned.Visual assessment of the inserter showed no abnormalities.Without the return of the anchor an exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: pathological conditions of the bone that would prevent secure fixation.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.

• Brand Name: TWINFIX ULTRA 4.5MM W/2 UB (BLK &BLUE)
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9795305
• Report Number: 1219602-2020-00472
• Device Sequence Number: 2874409
• Product Code: MBI
• UDI-Device Identifier: 03596010652256
• UDI-Public: 03596010652256
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2023
• Device Model Number: 72202894
• Device Catalogue Number: 72202894
• Device Lot Number: 50749358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1