MAUDE Adverse Event Report: SMITH & NEPHEW, INC. (5) SUTUREFIX AHR S (1) 2 UB BL 1.7; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203955
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during bankart repair procedure, the anchor post-deployment came out of the pilot drilled hole.An additional hole was made to complete the procedure and there was a void left in the patient.No significant delay and a back up was available to complete the procedure.No patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported 72203955 suturefix ahr s (1) 2 ub bl 1.7l, used in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customer's complaint cannot be confirmed.The complaint stated: ¿during bankart repair procedure, the anchor post-deployment came out of the pilot drilled hole¿.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include improper use of the device.Per the device's instructions for use: ¿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¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was preformed, no other complaints of this failure were found.Further investigation is not warranted at this time.

• Brand Name: (5) SUTUREFIX AHR S (1) 2 UB BL 1.7
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9945807
• Report Number: 1219602-2020-00633
• Device Sequence Number: 3293000
• Product Code: MBI
• UDI-Device Identifier: 00885554031881
• UDI-Public: 00885554031881
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2020

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 Model Number: 72203955
• Device Catalogue Number: 72203955
• Device Lot Number: 50775198
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2020
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 05/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1