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

Catalog Number 72200755

Device Problem Positioning Problem (3009)

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

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that, during an arthroscopic surgery, the "5.0 titanium twinfix anchor" came off the shaft while inserting the anchor into the bone hole.The anchor was reattached to the shaft and it was attempted to reinsert it into the bone hole, but it could not be inserted anymore.The procedure was successfully completed without delay using a back-up device.No patient injuries 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

The reported 72200755 twinfix ti 5.0 ultrabraid intended for use in treatment has been returned for evaluation.The information provided states: ¿during an arthroscopic surgery, the "5.0 titanium twinfix anchor" came off the shaft while inserting the anchor into the bone hole.The anchor was reattached to the shaft and it was attempted to reinsert it into the bone hole, but it could not be inserted anymore¿.Visual assessment showed sutures were cut.The anchor was returned damaged.Human matter was found on sutures.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied.Per instructions for use: ¿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¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was performed, no other complaints of this failure was found.Further investigation is not warranted at this time.

Event Description

It was reported that, during an arthroscopic surgery, the "5.0 titanium twinfix anchor" came off the shaft while inserting the anchor into the bone hole.The anchor was reattached to the shaft and it was attempted to reinsert it into the bone hole, but it could not be inserted anymore.In consequence, the faulty anchor was removed the patient.The procedure was successfully completed without delay using a back-up device.No patient injuries or other complications were reported.

• Brand Name: TWINFIX TI 5.0 ULTRABRAID
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10151688
• MDR Text Key: 195082816
• Report Number: 1219602-2020-00918
• Device Sequence Number: 1
• Product Code: JDR
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200755
• Device Lot Number: 2034372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1