MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX ULTRA AHR XL 2 UB BLUE/WH; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203842
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that after a left hip arthroscopy, the suture anchor introducer was found broken in the bone.Three lot numbers were provided (50621753, 50566979, 50608909) but it is unknown which one is the one that broke.The broken anchor guide piece identified in left hip.The implant was left in situ and no further complications were reported.
Additional Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.The customer provided image confirms a fragment embedded in the bone.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A review of risk management files found that the reported failure was documented appropriately.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as pre-cautions and warnings related to the use of the device.A review of print specifications, found material certification required with each lot.Certification to include statement of origin of manufacture identification.Clinical evaluation found that no further medical assessment is warranted at this time.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: SUTUREFIX ULTRA AHR XL 2 UB BLUE/WH
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12304812
• Report Number: 1219602-2021-01696
• Device Sequence Number: 3971263
• Product Code: MBI
• UDI-Device Identifier: 00885554031553
• UDI-Public: 00885554031553
• 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,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2021
• Device Model Number: 72203842
• Device Catalogue Number: 72203842
• Device Lot Number: 50621753
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 55