MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA 6.5MM W/3 UB; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202900
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a rotator cuff repair, the twinfix ultra inserter was partially damaged as it cracked inside of the patient.There were not any fragments to be removed.A back-up device was available to complete the procedure in a timely manner.The patient was not impacted.
Additional Manufacturer Narrative
One 6.5 twinfix ultra ti anchor assembly was returned for evaluation.Visual assessment of the device shows it is intact.Examination of the anchor confirmed attempted use as there is bio-material present.Anchor was tested for insertion using bone block material and was able to be inserted as intended.Removal of the anchor from the inserter showed no damage to the inserter tip.Shaft is properly aligned within the handle.The reported complaint of the inserter being cracked cannot be confirmed.The instruction for use was reviewed and was 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 6.5MM W/3 UB
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8900887
• Report Number: 1219602-2019-00972
• Device Sequence Number: 19340046
• Product Code: MBI
• UDI-Device Identifier: 03596010652324
• UDI-Public: 03596010652324
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2024
• Device Catalogue Number: 72202900
• Device Lot Number: 2034476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1