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	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during shoulder arthroscopy the suture anchor broke.All pieces were removed.The procedure was successfully completed without delay using a 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.
Event or Problem Description
It was reported that during shoulder arthroscopy the suture anchor broke.All pieces were removed.The procedure was successfully completed without delay using a back-up device in an additional bone hole.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 5.5 twinfix ultra pk anchor assembly, used in treatment, has not been returned for evaluation, however photographs were supplied.Examination of the photographs confirmed the reported complaint.The photo showed four devices, all of which show four device anchors broken at the suture eyelet.From the information provided, the anchors broke during insertion.An exact root cause cannot be determined with confidence with the limited clinical information provided; however, factors that could have contributed to the reported event include: not preparing the insertion site properly.Off axis insertion of the anchor.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 for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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 boulevard; mansfield MA 02048
• MDR Report Key: 9826274
• Report Number: 1219602-2020-00514
• Device Sequence Number: 11530380
• Product Code: MBI
• UDI-Device Identifier: 03596010647481
• UDI-Public: 03596010647481
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• PMA/510(K) Number: K093228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

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: 03/29/2024
• Device Model Number: 72202600
• Device Catalogue Number: 72202600
• Device Lot Number: 2030924
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1