MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PLLA/HA 5.5 W/3 UB; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72202603
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the twinfix tip was broken.The tip broke inside the patient, however all the pieces were removed.No additional holes were made to complete the procedure.No patient injuries were reported.
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.Further investigation is not warranted at this time.
Additional Manufacturer Narrative
Device was returned for evaluation.Visual assessment confirmed the reported breakage.The distal tip of the anchor has broken at the suture slot.The inserter tines are intact.The condition of the anchor indicates excessive force was placed on it during insertion.No root cause related to the manufacturing process can be established.Use error may have been a contributing factor to the event.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

• Brand Name: TWINFIX ULTRA PLLA/HA 5.5 W/3 UB
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6861299
• Report Number: 1219602-2017-01120
• Device Sequence Number: 1408364
• Product Code: MAI
• UDI-Device Identifier: 03596010647597
• UDI-Public: (01)03596010647597(17)211221(10)50637832
• Combination Product (Y/N): N
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2017

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 Expiration Date: 12/21/2021
• Device Model Number: 72202603
• Device Catalogue Number: 72202603
• Device Lot Number: 50637832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 09/08/2017; 11/07/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 10/18/2017; 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1