MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX CRVD AHR XL 1 #2 UB STR BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72205060
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery the anchor was fallen out, there was a loss of tissue fixation.A backup device was used to complete the surgery.
Additional Manufacturer Narrative
The reported suturefix curved ahr xl intended for use in treatment, was not 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 lost fixation, causing the anchor to come free from the insertion site.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: pathological conditions in the soft tissues to be attached that would impair secure fixation by suture.Comminuted bone surface, which would compromise secure anchor fixation.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
Additional information was received from the reporter stating that no additional bone hole was performed, therefore, no medical intervention was required.This event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
Event or Problem Description
It was reported that during an unspecified surgery the suturefix anchor fell out.There was a loss of tissue fixation with no additional bone hole required.A back-up device was used to complete the surgery.The surgery was not significantly delayed.The patient was not injured.

• Brand Name: SUTUREFIX CRVD AHR XL 1 #2 UB STR BL
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8493529
• Report Number: 1219602-2019-00398
• Device Sequence Number: 14125583
• Product Code: MBI
• UDI-Device Identifier: 00885556686300
• UDI-Public: 00885556686300
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K163034
• 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,Followup
• Report Date (Section B): 07/02/2019

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 Catalogue Number: 72205060
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/23/2019; 07/01/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 04/24/2019; 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1