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

Model Number	72203841
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during an acetabular labrum repair, one suturefix ultra anchor was damaged during insertion.In consequence, the anchor was pulled out of the patient.It was not used another device to replace it.It is unknown if successful fixation was achieved with the other four anchors that functioned as intended.It is unknown if surgery was delayed as a consequence of the allegation.The event was considered resolved and the patient is recovered.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported suturefix ultra anr xl intended for use in treatment, will not be returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the anchor pulled out.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: application of excessive force during use.Inappropriate insertion site preparation.Pathological conditions of the bone that would prevent secure fixation.The instruction for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.As reported during an acetabular labrum repair, one suturefix ultra anchor was damaged during insertion and the broken pieces were removed with graspers.Four other anchors were used and function as intended.It has been communicated that the event is considered resolved and the patient status has been reported as recovered.Since no patient harm is being alleged and no further harm is anticipated, no further assessment is warranted at this time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.
Event or Problem Description
It was reported that, during an acetabular labrum repair, one suturefix ultra anchor was damaged during insertion.In consequence, the anchor was pulled out of the patient.It was not used another device to replace it.It is unknown if successful fixation was achieved with the other four anchors that functioned as intended.Broken pieces were removed with graspers and there was a 2 minutes delay.The event was considered resolved and the patient is recovered.
Additional Manufacturer Narrative
Additional information was received.
Event or Problem Description
It was reported that, during an acetabular labrum repair, one suturefix ultra anchor was damaged during insertion.In consequence, the anchor was pulled out of the patient.It was not used another device to replace it.It is unknown if successful fixation was achieved with the other four anchors that functioned as intended.Broken pieces were removed with graspers and there was no delay reported.The event was considered resolved and the patient is recovered.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 9347735
• Report Number: 1219602-2019-01458
• Device Sequence Number: 19372538
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/16/2023

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: 01/24/2024
• Device Model Number: 72203841
• Device Catalogue Number: 72203841
• Device Lot Number: 2027407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 11/25/2019; 12/17/2019; 12/21/2020; 05/27/2021; 03/14/2023
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 11/28/2019; 12/30/2019; 01/05/2021; 06/18/2021; 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown