MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX UL ANR XL W/1 2 ULTRABRIAD BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72203841
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a surgery, the suturefix xl anchor inserter broke off in the drill hole on deployment of the anchor.It was then retrieved from the hole via a grasper.The metal prong and some suture was retrieved once the area was cleared.A backup device was available to complete the procedure successfully.Delay or patient injuries were not reported.
Additional Manufacturer Narrative
One 72203841 suturefix ultra anchor xl devices used for treatment, was returned for evaluation.There was a relationship between the reported event and the device.The complaint stated: ¿anchor inserter broke off in the drill hole on deployment of the anchor.¿ the inserter shaft is damaged and broken.The outer tube was bent.The inner shaft distal fork tine area has been fractured.All metal components and pieces were returned and accounted for.Blue ultrabraid suture was returned, but the textile anchor was absent.Symptoms are consistent with loss of axial alignment during insertion attempt.Highlights several precautions that affect successful fixation.¿use of excessive force during insertion can cause failure of the suture anchor or insertion device.Only use the recommended drill bits and drill guides intended for use with the suturefix ultra suture anchor.Use of other instruments may injure the patient, damage the instruments, or compromise fixation.Do not use sharp instruments to manage or control the suture.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.¿ complaint history review found no other reports for this lot number.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.

• Brand Name: SUTUREFIX UL ANR XL W/1 2 ULTRABRIAD BL
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8683495
• Report Number: 1219602-2019-00664
• Device Sequence Number: 19410321
• Product Code: MBI
• UDI-Device Identifier: 00885554030051
• UDI-Public: 00885554030051
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

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: 03/23/2023
• Device Catalogue Number: 72203841
• Device Lot Number: 50722873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1