MAUDE Adverse Event Report: I.T.S. GMBH TORQUE-SHANK, T5X80 AO CONNECTOR

Model Number	54101-80
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have inspected the dhf of the affected lot including material certificate and the batch was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.The article met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The verification of the returned devices showed no deviations.The screwdriver has a twisted profile, the tip is broken off.The fracture surface is completely twisted and rounded.The twisting of the profile is clearly visible on the outer tips.Due to the twisted fracture surface, it is not possible to make a precise statement about the cause of the breakage, but it can be assumed that the screwdriver was used with a cordless screwdriver and not by hand, as the degree of twisting indicates a very large number of rotations, which are difficult to perform by hand.There surgery could be finished with a substitute screwdriver shank and there was no delay noted.Based on the information available, it has been determined that no corrective and preventative action is proposed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that a t5 screwdriver shank broke during surgery.There were no delays in surgery.Device was used for treatment, not diagnosis.

• Brand Name: TORQUE-SHANK, T5X80 AO CONNECTOR
• Common Device Name: TORQUE-SHANK, T5X80 AO CONNECTOR
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• Manufacturer (Section G): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• Manufacturer Contact: florian grill ; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 16944603
• Report Number: 3004369035-2023-00007
• Device Sequence Number: 6376116
• Product Code: HXX
• UDI-Device Identifier: 09120047305478
• UDI-Public: 09120047305478
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 54101-80
• Device Catalogue Number: 54101-80
• Device Lot Number: 18/124327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown