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	Foreign Body In Patient (2687)
Date of Event	01/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anchor screw broke during insertion inside the patient.All pieces were removed.The procedure was completed with the same device.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.

• 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: 7270206
• Report Number: 1219602-2018-00219
• Device Sequence Number: 136226
• Product Code: MAI
• UDI-Device Identifier: 03596010647597
• UDI-Public: (01)03596010647597(17)220313(10)50652537
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2018

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: 03/13/2022
• Device Model Number: 72202603
• Device Catalogue Number: 72202603
• Device Lot Number: 50652537
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR