MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 5.0 ULTRABRAID; STAPLE, FIXATION, BONE

Catalog Number 72200755

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/28/2019

Event Type  malfunction  

Event Description

It was reported that during a shoulder rotator cuff repair surgery, the twinfix titanium 5.0 was found broke when screw-in.All foreign matter were removed from the patient.The procedure was completed without 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

One twinfix ti 5.0 ultrabraid assembly was returned for evaluation.Visual assessment of the device showed the anchors eyelet and proximal threads are damaged.One leg of blue co-braid suture approximately 20 inches in length was returned and is frayed at one end.Examination of the inserter confirmed the distal hex where the anchor interfaces is stripped.The condition of the device indicates it was subjected to excessive force during insertion.Per the device instruction for use under precautions: 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.

• Brand Name: TWINFIX TI 5.0 ULTRABRAID
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9395420
• MDR Text Key: 168623884
• Report Number: 1219602-2019-01511
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010577986
• UDI-Public: 03596010577986
• 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: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2022
• Device Catalogue Number: 72200755
• Device Lot Number: 50702260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1