MAUDE Adverse Event Report: ORTHO SOLUTIONS UK LIMITED ULTOS¿ T8 TORX DRIVER; SCREWDRIVER

Model Number	OS328025-NS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fractured screwdriver is to be sent to an external laboratory for fracture and defect analysis.Upon return and further investigation into the reported condition, the report will be updated to provide a summary of the investigation conclusions and any appropriate corrective actions to be implemented.
Event or Problem Description
The t8 torx driver tip sheared off flush in the head of a 3.5mm locking screw (fifth screw in the operation) for a 1st mtpj procedure.The broken section of the driver could not be retrieved.The driver is made of 420c stainless steel which is non-implantable.
Additional Manufacturer Narrative
A review of the device history records for the batch revealed no deviation in material or manufacture which would have contributed to the complaint condition.The returned driver was visually inspected and analysed at an external laboratory via sem fractography and hardness testing.Sem fractography characterised the mode of failure as torsional overloading, and surveys of the fracture surface revealed no material discontinuities.Hardness testing verified the conformance of the material and manufacturing process to specification.It was determined the possible cause of failure was mechanical overloading.Since this is a reusable device, it is not possible to determine if the fracture occurred due to a single torsional overload event or accumulative wear and tear occurring over multiple uses.The loan kit has been replaced with a new driver, which we will monitor as part of our post-market surveillance, to ensure that the device continues to meet our standards of safety and performance.
Event or Problem Description
The t8 torx driver tip sheared off flush in the head of a 3.5mm locking screw (fifth screw in the operation) for a 1st mtpj procedure.The broken section of the driver could not be retrieved.The driver is made of 420c stainless steel which is non-implantable.

• Brand Name: ULTOS¿ T8 TORX DRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): ORTHO SOLUTIONS UK LIMITED; west station business park; spital road; maldon, essex, CM9 6 FF; UK CM9 6FF
• MDR Report Key: 8806144
• Report Number: 3008951116-2019-00003
• Device Sequence Number: 2688089
• Product Code: HXX
• UDI-Device Identifier: 05055662948479
• UDI-Public: 05055662948479
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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: No Information
• Device Model Number: OS328025-NS
• Device Lot Number: 601174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other