MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 6MM X 20MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204391
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an acl reconstruction procedure, after deploying of the screw biosure regenesorb 6mm x 20mm, the device had a break in the proximal part.The procedure was completed with the same device with no delay nor patient injury.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 received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the outer packaging contained a handwritten batch number.A small fragment of the screw was returned.It appeared to have sheared off of the proximal end of the device.Based on the condition of the product material found during visual inspection it was determined that additional material testing is not required.A review of the device 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.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of the material specifications found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force, off-axis insertion, improper preparation of the insertion site, or use of a damaged driver.No containment or corrective actions are recommended at this time.

• Brand Name: SCREW BIOSURE REGENESORB 6MM X 20MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11592776
• Report Number: 1219602-2021-00751
• Device Sequence Number: 4845953
• Product Code: MAI
• UDI-Device Identifier: 00885554036671
• UDI-Public: 00885554036671
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 05/21/2021

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 Model Number: 72204391
• Device Catalogue Number: 72204391
• Device Lot Number: 50831360
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 05/21/2021
• 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: Required Intervention