MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWNFX TI 2.8 HS STR ANCHR 2 DRBRD NDL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	7210301
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during proximal humerus avulsion surgery, the suture broke when knotting.A backup device was available to complete the procedure with no significant delay or patient injuries.
Additional Manufacturer Narrative
One 2.8 twinfix ti anchor w/needles was returned for evaluation.Visual assessment of the device confirmed the reported suture breakage.The white leg of suture was returned and is broken approximately mid-point of its length.The needle is missing from one end of the suture and was not returned for examination.The suture is heavily frayed at the break area.The anchor is free from the inserter and its eyelet is slightly deformed.The condition of the suture indicates it came in contact with a sharp edge resulting in the breakage.

• Brand Name: TWNFX TI 2.8 HS STR ANCHR 2 DRBRD NDL
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8228767
• Report Number: 1219602-2019-00044
• Device Sequence Number: 1910281
• Product Code: MBI
• UDI-Device Identifier: 03596010533845
• UDI-Public: 03596010533845
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K972326
• 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): 02/11/2019

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: 03/31/2019
• Device Catalogue Number: 7210301
• Device Lot Number: 50501359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR