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 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
Evaluation was not possible, as the devices have not been returned, however photos were supplied.Examination of the photos showed two 5.5 twinfix ultra plla/ha assemblies with broken anchors confirming the reported complaint of breakage.The anchors are broken at their suture slots.With the limited clinical details and the lack of the devices no root cause can be determined.Further investigation is prohibitive at this time.(b)(4).
Additional Manufacturer Narrative
One 5.5 twinfix ultra plla/ha anchor assembly was returned for evaluation.Visual assessment confirmed the reported breakage.The distal tip of the anchor has broken above the suture slot.The inserter tines are intact.The condition of the anchor indicates excessive force was placed on it during insertion.Per the device ifu ¿caution: use of excessive force during insertion can cause failure of the suture anchor or insertion device¿.No root cause related to the manufacturing process can be established.Further investigation is not warranted at this time.

• 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: 6861308
• Report Number: 1219602-2017-01121
• Device Sequence Number: 706389
• 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: consumer,foreign,health profe
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2017

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 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: 10/24/2017; 11/07/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 10/25/2017; 11/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1