MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 9MM X 25MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72204404
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during surgery, the device broke while being implanted.All the pieces were removed from within the patient.There was a backup device available to successfully complete the procedure.A delay greater than 30 min was reported.No patient injury was reported.
Additional Manufacturer Narrative
The reported device, 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 screw broke during insertion.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: improper site preparation or excessive force placed on the screw during insertion.The instructions 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.A complaint history review identified no additional complaints for this manufactured lot.
Event or Problem Description
It was reported that during a surgery, the device broke in several pieces while it was being implanted.Each piece was removed from the patient with tweezers, which resulted in a surgical delay greater than 30 min.There was a backup device available to complete the procedure with no patient injuries.

• Brand Name: SCREW BIOSURE REGENESORB 9MM X 25MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9119184
• Report Number: 1219602-2019-01171
• Device Sequence Number: 19535884
• Product Code: MAI
• UDI-Device Identifier: 00885554036800
• UDI-Public: 00885554036800
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142948
• 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
• Report Date (Section B): 10/28/2019

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: 01/29/2022
• Device Catalogue Number: 72204404
• Device Lot Number: 50784880
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 53