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

Model Number 72200750

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2019

Event Type  malfunction  

Event Description

It was reported that during surgery, at the time of releasing the anchor from the shaft, the suture was released from the anchor and broken.It is unknown whether there was a back up available or delay in the case.The procedure was completed.Per customer response, the anchor was left inside the patient, which could indicates that another bone hole was necessary to implant the backup anchor.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One 72200750 twinfix ti 2.8mm ultrabraid suture anchor device was used for treatment and returned for evaluation.No anchor was returned.A strand of frayed, broken suture was returned separated from the device.There is no obvious bow or damage of the insertion shaft.The hex appears unaffected.There was no cause for failure observed.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.Dhr/batch/lot review did not indicate a condition or product/procedure failure that supported the allegation.Product met specifications upon release to distribution.No root cause related to the manufacture of this device can be confirmed.

Event Description

It was reported that during surgery, at the time of releasing the anchor from the shaft, the suture was released from the anchor and broken.It is unknown whether there was a back up available or delay in the case.The procedure was completed.Per customer response, the anchor was left inside the patient, which could indicate that another bone hole was necessary to complete the procedure.

• Brand Name: TWINFIX TI 2.8 ULTRABRAID
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9351662
• MDR Text Key: 167333803
• Report Number: 1219602-2019-01466
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010584472
• UDI-Public: 03596010584472
• 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: 01/23/2020

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: 01/22/2024
• Device Model Number: 72200750
• Device Catalogue Number: 72200750
• Device Lot Number: 50783241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1