MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA 5.5MM W/2 UB (BLK & BLUE); FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202896
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during surgery, the setting tool had broken off the twinfix ultra anchor although the hole was prepared with the appropriate awl.Back-up device was available to complaint the surgery with no significant delay.No other complications were reported.
Additional Manufacturer Narrative
The reported 5.5 twinfix ultra ti anchor assemblies, used in treatment, have been returned for evaluation.Visual assessment showed no sutures or anchor remain attached to the inserter.The anchor is heavily soiled with human matter and are damaged at its proximal end were it interfaces with the inserter.Examination of the inserters showed the distal tip has broken off at the weldment and was not returned.Examination of the shaft at the weldment showed adequate weld penetration.The condition of the devices indicate they were subjected to excessive forces during use.A two-finger ao technique should be used to insert the anchor¿.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.Conclusion: three photos provided that show the broken device.According product evaluation, the condition of the device indicate they were subjected to excessive forces during use.Per the device ifu ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device.¿ therefore, we cannot rule out a procedural vs user error as the likely root cause of the reported event.The broken pieces of the setting tool are non-implantable, therefore, the possibility of local skin irritation, micromotion/migration of the retained pieces of the broken device cannot concluded.Based on the limited information provided, the future impact to the patient cannot be determined.Per report, this procedure completed with a backup without significant delay with no further harm being alleged to this patient.Therefore, no further clinical medical assessment is warranted at this time.Should any additional medical information be provided this complaint would be re-assessed.

• Brand Name: TWINFIX ULTRA 5.5MM W/2 UB (BLK & BLUE)
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 10116688
• Report Number: 1219602-2020-00841
• Device Sequence Number: 14293122
• Product Code: MBI
• UDI-Device Identifier: 03596010652270
• UDI-Public: 03596010652270
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K100159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2024
• Device Model Number: 72202896
• Device Catalogue Number: 72202896
• Device Lot Number: 2036282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other