MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 9MM X 20MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72204403
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery the screw cracked while the surgeon was inserting it.No patient injuries or significant delay reported.Surgery was finished using a competitor device.All the broken pieces were removed from the patient's anatomy.
Additional Manufacturer Narrative
The reported one 9x20mm biosure regenesorb screw, intended for use in treatment, will not be returned for evaluation.Without the reported product and pertinent clinical details a thorough investigation cannot be performed and the customers complaint confirmed.From the information provided, screw broke during insertion.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: using the incorrect driver.Excessive force placed on the screw during insertion.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.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SCREW BIOSURE REGENESORB 9MM X 20MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8952879
• Report Number: 1219602-2019-01047
• Device Sequence Number: 13985566
• Product Code: MAI
• UDI-Device Identifier: 00885554036794
• UDI-Public: 00885554036794
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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 Expiration Date: 03/05/2021
• Device Catalogue Number: 72204403
• Device Lot Number: 50718727
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 08/31/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1