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

Device Problems Break (1069); Loose or Intermittent Connection (1371)

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

Event Date 04/05/2019

Event Type  malfunction  

Event 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.

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
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8565787
• MDR Text Key: 143678787
• Report Number: 1219602-2019-00485
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010647535
• UDI-Public: 03596010647535
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K093228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 76