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	01/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the anchor broke while screwed in.All the pieces were removed.A backup device was available to complete the procedure with no significant delay and no patient injuries.
Additional Manufacturer Narrative
Additional information.Correction.
Event or Problem Description
It was reported that during a shoulder surgery, the anchor broke while screwed in.All the pieces were removed.There was no loss of tissue or bone due to the event.A backup device was available to complete the procedure with no significant delay and no patient injuries.
Additional Manufacturer Narrative
One 5.5 twinfix ultra pk anchor assembly was returned for evaluation.Visual assessment of the anchor confirmed the reported breakage.The anchor has broken at the suture eyelet.Dimensional assessment of the anchors major diameter found it met print specifications.The inserter tines that interface with the anchor were also examined and noted to be intact.The condition of the anchor indicates it was subjected to excessive force during insertion.

• 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: 8325168
• Report Number: 1219602-2019-00170
• Device Sequence Number: 19261750
• Product Code: MBI
• UDI-Device Identifier: 03596010647535
• UDI-Public: 03596010647535
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 03/12/2019

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 Catalogue Number: 72202625
• Device Lot Number: 2013881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 02/21/2019; 03/11/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 02/21/2019; 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR