MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 5.5MM W/3UB-WHT,BL &BLK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202600
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 5.5 twinfix ultra pk anchor assembly was returned for evaluation.Visual assessment confirmed the reported breakage.The distal tip of the anchor has broken at the suture eyelet.Dimensional analysis of the anchor found it met print specifications.With the limited clinical details regarding patient bone quality and procedure being performed, a root cause cannot be determined.This investigation could not identify any evidence of product contribution to the reported complaint.
Event or Problem Description
It was reported that during application of the anchor, it broke.The hole was prepared with the 3,8 mm awl.No patient injuries and minor delay were reported.A backup was used to complete the procedure.

• Brand Name: TWINFIX ULTRA PK 5.5MM W/3UB-WHT,BL &BLK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7739213
• Report Number: 1219602-2018-00978
• Device Sequence Number: 19468374
• Product Code: MBI
• UDI-Device Identifier: 03596010647481
• UDI-Public: (01)03596010647481(17)221201(10)50700317
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: 72202600
• Device Catalogue Number: 72202600
• Device Lot Number: 50700317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR