MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 6MM X 25MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204392
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that upon implantation into the calcaneum pre drilled tunnel (6mm diameter) to secure the fhl tendon, the product breaks into pieces.The issue was completed with a back-up implant (smith and nephew biosure ha screw 6 x 25mm).Broken pieces of the implant were taken out and there was no patient harm caused.However, the procedure was delayed for another 15min.No additional bone holes were required.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found: o breakage of the screw or loss of fixation may occur if the insertion site is not prepared properly o inspect to confirm that the interference screw is fully seated onto the driver prior to insertion.If the interference screw is not properly seated on the driver, damage to or breakage of the screw may result 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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: SCREW BIOSURE REGENESORB 6MM X 25MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10718842
• Report Number: 1219602-2020-01631
• Device Sequence Number: 3345700
• Product Code: MAI
• UDI-Device Identifier: 00885554036688
• UDI-Public: 00885554036688
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K142948
• 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): 01/10/2021

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: 08/24/2021
• Device Model Number: 72204392
• Device Catalogue Number: 72204392
• Device Lot Number: 50754807
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 01/10/2021
• 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; Required Intervention