MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE RATCHET DRIVER; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72201888
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during an acl surgery, the tip of the biosure driver had become flared out due to continued use, causing three biosure regenesorb screws to break during insertion.The broken pieces were retrieved using forceps, haemostat, and suction.The surgery was completed with a change in the surgical technique.There was no surgical delay, and no further complications were reported.
Additional Manufacturer Narrative
Corrected data: b5, d1, d2a, d2b, d4, d10.
Event or Problem Description
It was reported that during an acl surgery, the tip of the biosure driver (case (b)(4)) has become flared out due to continued use.This caused three biosure regenesorb screws to break during insertion.The broken pieces were retrieved using forceps, homeostat and suction.The surgery was completed with a change in the surgical technique.There was no surgical delay, and no further complications were reported.
Additional Manufacturer Narrative
H2: corrected information in h6 (investigation findings & component code).H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The distal tip of the driver has flared out and deformed.The failure is associated with a well-known failure mode that has been thoroughly investigated in prior complaints.No new information, trends, or patient impact were identified that would warrant further review.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, or an inadvertent impact event inconsistent with normal use).Based on this investigation, the need for corrective action is not indicated.

• Brand Name: BIOSURE RATCHET DRIVER
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22473620
• Report Number: 1219602-2025-01726
• Device Sequence Number: 4272463
• Product Code: NBH
• UDI-Device Identifier: 03596010615442
• UDI-Public: 3596010615442
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2025

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: 72201888
• Device Lot Number: 50683658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 08/08/2025; 08/28/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/08/2025; 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SCREW BIOSURE REGENESORB 7MM X 30MM, LOT: 51128587; SCREW BIOSURE REGENESORB 8MM X 30MM, LOT: 51121835; SCREW BIOSURE REGENESORB 9MM X 30MM, LOT: 51114535
• Patient Age: 17 YR
• Patient Sex: Female