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

Catalog Number	72202893
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic surgery with a normal awl, the anchor cannot be implanted.An additional bone hole was made to complete the procedure.A backup device was available to complete the procedure with no significant delay and no patient injuries.
Additional Manufacturer Narrative
One (b)(4) twinfix ultra ti 4.5mm suture anchor device returned.¿the anchor cannot be implanted.¿ recommended prep instruments are a spade drill tip and a tapered awl.Insertion device, sutures and anchor were returned.The anchor has been fractured and sheared from force.Threads are damaged.The head of the anchor has been damaged.The inserter has been damaged where the anchor mates.The symptoms indicate excess torque and loss of axial alignment contributed to the failure.The hex tip appears to have the head of the anchor snapped off inside.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.No root cause related to the manufacture of this device was confirmed.

• Brand Name: TWINFIX ULTRA TI 4.5 W/2 UB (WH & BLUE)
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8416186
• Report Number: 1219602-2019-00299
• Device Sequence Number: 2989751
• Product Code: MBI
• UDI-Device Identifier: 03596010652287
• UDI-Public: 03596010652287
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 03/29/2019

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: 05/14/2023
• Device Catalogue Number: 72202893
• Device Lot Number: 50735304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 49