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

Model Number	72204404
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during a procedure screw broke while screwing in.The procedure was successfully completed without any significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h3,h6: the reported 9x25mm biosure regenesorb screw, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be 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: not preparing the insertion site properly.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
The reported 72204404 screw biosure regenesorb 9mm x 25mm, used in treatment, has been returned for evaluation.From the information provided, ¿during a procedure screw broke while screwing in¿.Visual assessment confirms complaint.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during insertion.Improper site preparation.The instruction for use outlines 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 review of complaints and manufacturing batch records was performed, no other complaints of this failure was found.

• 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: 9654508
• Report Number: 1219602-2020-00157
• Device Sequence Number: 1877303
• Product Code: MAI
• UDI-Device Identifier: 00885554036800
• UDI-Public: 00885554036800
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2020

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 Expiration Date: 10/19/2020
• Device Model Number: 72204404
• Device Catalogue Number: 72204404
• Device Lot Number: 50691809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 03/11/2020; 06/26/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 03/12/2020; 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR