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	09/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when screwing the anchor the peak broke.No patient injuries were reported.
Additional Manufacturer Narrative
One 5.5mm twinfix ultra pk anchor assembly was returned for evaluation.Visual assessment of the device confirmed the anchor breakage.The anchor has broken on one side of the suture eyelet.Removal of the anchor showed the inserter tines are bent.The condition of the inserter and anchor are consistent with off axis insertion.Per the device ifu ¿establish axial alignment of the suture anchor to the insertion site.While supporting the insertion site, rotate the anchor clockwise into the insertion site with the insertion device using a two-finger ao technique.Continue rotating the anchor until desired placement is achieved by visual inspection¿.A review of the device history records and quality records associated with this manufactured lot confirmed that no additional complaints have been filed and that no abnormalities were reported with this product during manufacture.Due to these observations no root cause related to the manufacturing process can be established.
Event or Problem Description
It was reported that when screwing in the anchor, the peak broke.All broken pieces were removed from the surgical site.Procedure was completed using a back-up device.No patient injuries or other complications were reported.

• 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: 6885053
• Report Number: 1219602-2017-01177
• Device Sequence Number: 18996558
• Product Code: MBI
• UDI-Device Identifier: 03596010647481
• UDI-Public: (01)03596010647481(17)210720(10)50612106
• Combination Product (Y/N): N
• PMA/510(K) Number: K093228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2017

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 Model Number: 72202600
• Device Catalogue Number: 72202600
• Device Lot Number: 50612106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR