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 Crack (1135); Loose or Intermittent Connection (1371); Device Fell (4014)

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

Event Date 03/11/2019

Event Type  malfunction  

Event Description

It was reported that during rotator cuff repair, the twinfix anchor cracked with piece falling off it as was being screwed in to place.The loose piece was removed.The rest of the implant stayed in and was used to secure the cuff down.Delay or patient injuries were not reported.

Manufacturer Narrative

The reported twinfix ultra pk 5.5mm intended for use in treatment, was not returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the twinfix anchor cracked with pieces falling off it as it was being screwed into place.Without the return of the device 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 can cause failure of the suture anchor or insertion device.A two-finger ao technique should be used to insert the anchor.The instruction for use (10600571) were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 8423048
• MDR Text Key: 139044476
• Report Number: 1219602-2019-00306
• 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: 04/26/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2023
• Device Catalogue Number: 72202625
• Device Lot Number: 2016192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 04/25/2019
• Supplement Dates FDA Received: 04/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2018
• 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