MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 10MM X 30MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204409
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the biosure screw got broken directly by placing, the device did not break, but distorted.The screw was spinning and removed.The procedure was completed with a s+n back up device.There was no surgical delay and no further complications were reported.The bone quality was normal.The back up device was used in the originally drilled bone hole.There was no void left in the patient.The instrument used to prepare the insertion site was a 9.5 cann drill bit size and the tunnel size was 9,5.The insertion site was cleared of all debris prior to insertion of the anchor.The patient status had a normal recovery.The surgeon was ultimately satisfied with the surgical outcome.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.The original information indicated the anchor broke; however, additional information indicates it actually distorted, therefore there was no injury or damage caused by the device malfunction.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.
Event or Problem Description
It was reported that during an arthroscopy, when placing the biosure screw, it distorted.The screw was spinning and removed.The procedure was completed with non-surgical delay using a s+n back up device and no further complications.The back up device was used in the originally drilled bone hole and no void was left in the patient.The insertion site was cleared of all debris prior to insertion of the anchor.The patient had a normal recovery and the surgeon was ultimately satisfied with the surgical outcome.

• Brand Name: SCREW BIOSURE REGENESORB 10MM X 30MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16103054
• Report Number: 1219602-2023-00029
• Device Sequence Number: 3238465
• Product Code: MAI
• UDI-Device Identifier: 00885554036855
• UDI-Public: 00885554036855
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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 Expiration Date: 05/03/2025
• Device Model Number: 72204409
• Device Catalogue Number: 72204409
• Device Lot Number: 51027419
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown