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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during hip arthroscopy labral repair surgery, the anchor was implanted but it did not get a good grip because of poor bone quality.A backup was used in an additional bone hole.No delay or patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H2, h6.The reported suturefix ultra ahr s anchor assembly, intended for use in treatment, will not be returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the anchor pulled out of the patients bone.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: pathological conditions of the bone that would prevent secure fixation.The instruction for use outlines precautionary statements and instructions in during deployment.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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 boulevard; mansfield MA 02048
• MDR Report Key: 9999259
• Report Number: 1219602-2020-00682
• Device Sequence Number: 19943907
• Product Code: MBI
• UDI-Device Identifier: 00885554031553
• UDI-Public: 00885554031553
• Combination Product (Y/N): N
• PMA/510(K) Number: K122059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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: 10/17/2022
• Device Model Number: 72203842
• Device Catalogue Number: 72203842
• Device Lot Number: 50691241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 04/25/2020
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1