MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 2.8 ULTRABRAID; STAPLE, FIXATION, BONE

Catalog Number 72200750

Device Problem Unintended Ejection (1234)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2020

Event Type  malfunction  

Event Description

It was reported that during an elbow surgery the twin-fix anchor was found screw'slip and can not be implanted.The procedure was successfully completed without a significant 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.

Manufacturer Narrative

H10 h3, h6: one 72200750 twinfix ti 2.8mm ultrabraid suture anchor device used for treatment, was returned for evaluation.Instructions for use contains recommendations and precautionary statements for proper use of product.The insertion device was returned with anchor.A strand of suture was returned.The anchor threads were damaged.The allegation indicated that the anchor ¿slipped¿ during attempted use.This symptom is aligned with loss of axial alignment.Instructions for use contains technique driven instructions, specific warnings and recommendations for use: ¿breakage of suture anchor can occur if predrilling is not performed prior to implantation.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Read these instructions completely prior to use.¿ complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.There was no evidence to suggest that product from this family did not pass requirements upon release for use.No root cause related to the manufacture of this device can was confirmed.

• Brand Name: TWINFIX TI 2.8 ULTRABRAID
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10067947
• MDR Text Key: 191388736
• Report Number: 1219602-2020-00792
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010584472
• UDI-Public: 3596010584472
• Combination Product (y/n): N
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/08/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Catalogue Number: 72200750
• Device Lot Number: 50735397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/18/2020
• Supplement Dates Manufacturer Received: 06/04/2020
• Supplement Dates FDA Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 56