MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWNFX TI 5.0 STR ANCHR W/2 ULTRB STR N; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	7210708
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw was broken inside the tibia bone.No delay nor patient injuries were reported.A backup was available to complete the procedure.
Additional Manufacturer Narrative
Examination is not possible, as the device will not be 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: TWNFX TI 5.0 STR ANCHR W/2 ULTRB STR N
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7864819
• Report Number: 1219602-2018-01226
• Device Sequence Number: 16574079
• Product Code: MBI
• UDI-Device Identifier: 03596010532206
• UDI-Public: (01)03596010532206(17)230611(10)50740699
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K972326
• 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,Followup
• Report Date (Section B): 10/03/2018

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: 06/11/2023
• Device Model Number: 7210708
• Device Catalogue Number: 7210708
• Device Lot Number: 50740699
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1