MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 9MM X 30MM; SCREW, FIXATION, BONE

Catalog Number	72201782
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy, the biosure anchor broke during implantation.The procedure was completed using a s+n back up device used in the originally drilled bone hole.No void was left in the patient.There was a delay less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 b5: event description updated.Internal complaint reference (b)(4).H11 h6: health effect - impact code updated.The information received by the manufacturer has been re-evaluated for mdpr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Additional information received by the reporter states the device broke outside the patient and the back up device was used in the same bone hole, which would not represent any risk or damage to the patient.This event is considered not reportable in accordance with applicable regulations.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, the biosure anchor broke outside the patient.The procedure was completed using a s+n back up device used in the originally drilled bone hole.No void was left in the patient.There was a delay less than 30 minutes and no further complications were reported.

• Brand Name: BIOSURE HA 9MM X 30MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 19377136
• Report Number: 1219602-2024-01124
• Device Sequence Number: 7619306
• Product Code: HWC
• UDI-Device Identifier: 03596010611789
• UDI-Public: 03596010611789
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2024

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 Catalogue Number: 72201782
• Device Lot Number: 51021041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 55 KG