MAUDE Adverse Event Report: ORTHO SOLUTIONS UK LTD ORTHO SOLUTIONS ANKLE FRACTURE PLATING SYSTEM; T10 SCREWDRIVER BIT, SELF-RETAINING

Model Number	OS721010-NS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The tip of the screwdriver shank was reported to have fractured intraoperatively along with a screw.This caused a minor delay to surgery to remove the fractured screw including an additional incision.Another screwdriver shank of the same product code and lot number was reported to have deformed at the tip during use.It was confirmed that the surgery was ultimately completed successfully with no further impact on the patient or user.
Additional Manufacturer Narrative
A recall was initiated of os721010-ns lot 915999 (manufacturer reference: capa 003-25) due to the potential link identified between its dimensional nonconformance and the event reported in (b)(6).Only two further devices of this lot were in the field, both in the uk.This recall has now been completed successfully.As the recall only affected this one batch, none of which have been sold or distributed in the usa, no field safety corrective actions are applicable to the usa for this issue.An additional report will be submitted for the screw which fractured in the same event.

• Brand Name: ORTHO SOLUTIONS ANKLE FRACTURE PLATING SYSTEM
• Common Device Name: T10 SCREWDRIVER BIT, SELF-RETAINING
• Manufacturer (Section D): ORTHO SOLUTIONS UK LTD; west station business park; spital road; maldon, essex CM9 6 FF; UK CM9 6FF
• Manufacturer Contact: jenny burns ; west station business park; spital road; maldon, essex CM9 6-FF ; UK CM9 6FF
• MDR Report Key: 22749319
• Report Number: 3008951116-2025-00002
• Device Sequence Number: 9120416
• Product Code: HXX
• UDI-Device Identifier: 05055662962833
• UDI-Public: 05055662962833
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K202764
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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: OS721010-NS
• Device Catalogue Number: OS721010-NS
• Device Lot Number: 915999
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown