MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 8MM X 30MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204401
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case(b)(4).
Event or Problem Description
It was reported that a revision surgery had to be performed after 8 months due to a patient's accident where the cruciate ligament tore again.During surgery it was discovered that the screw was virtually no longer present, it was a gel/rubber-like substance that had to be removed with a sharp spoon.It is unknown if a back-up device was available.No significant delays occurred.Patient outcome is unknown.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 the instructions for use found: read these instructions completely prior to use.Incomplete screw insertion may result in poor screw performance.The smith & nephew biosure¿ regenesorb interference screw is an absorbable biocomposite interference screw with open lateral surface area for use in the fixation of ligament, tendon, soft tissue, or bone-tendon-bone repairs in knee procedures.A review of risk management files found that the reported failure was documented appropriately.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.No containment or corrective actions are recommended at this time.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 8MM X 30MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11064694
• Report Number: 1219602-2020-02138
• Device Sequence Number: 4396693
• Product Code: MAI
• UDI-Device Identifier: 00885554036770
• UDI-Public: 00885554036770
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/18/2021
• Device Model Number: 72204401
• Device Catalogue Number: 72204401
• Device Lot Number: 50759567
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR