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

Catalog Number	72202625
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the anchor snapped during insertion into bone.No patient injuries reported and no delay.The procedure was successfully completed with the same device.All the pieces from the loose body anchor were retrieved with a arthroscopic grasper.
Additional Manufacturer Narrative
One 5.5 twinfix ultra pk anchor assembly was returned for evaluation.Only the proximal end of the anchor was returned, no inserter, sutures or packaging.Visual assessment confirmed the reported breakage.The distal tip of the anchor has broken at the suture eyelet.The break is angular in nature indicating off axis insertion.Dimensional assessment of the anchor major diameter and wall thickness was performed confirming it met print specifications.Without the return of the inserter an exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: use of excessive force during insertion which can cause failure of the suture anchor or insertion device.A two-finger ao technique should be used to insert the anchor.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.This investigation could not identify any evidence of product contribution to the reported complaint.

• Brand Name: TWINFIX ULTRA PK 5.5MM W/ 2 UB-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: 8565787
• Report Number: 1219602-2019-00485
• Device Sequence Number: 11172385
• Product Code: MBI
• UDI-Device Identifier: 03596010647535
• UDI-Public: 03596010647535
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 05/03/2019

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: 05/04/2023
• Device Catalogue Number: 72202625
• Device Lot Number: 2013988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 76