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	02/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that anchor was inserted into the bone and when the needles where deployed, it was found that only 3 of the 4 suture had needles on and the third one broke off from the suture during deployment.Surgeon used an curved mayo needle from the pharmacy in order to complete suturing.No significant delay or patient injury reported.
Additional Manufacturer Narrative
Definitive conclusions, accurate investigation and evaluation are not possible since product was not returned by customer for evaluation.No further actions pursued at this time.A manufacturing dhr review was performed by investigator revealed no other complaints or non-conformities for complained production lot.

• 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: 7368645
• Report Number: 1219602-2018-00370
• Device Sequence Number: 1031106
• Product Code: MBI
• UDI-Device Identifier: 03596010532206
• UDI-Public: (01)03596010532206(17)221027(10)50693525
• Combination Product (Y/N): N
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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: 10/27/2022
• Device Model Number: 7210708
• Device Catalogue Number: 7210708
• Device Lot Number: 50693525
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 03/24/2018
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1