MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKING SET; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	702753
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "during the removal operation of the proximal humerus plate of axos, the locking screw was hard and the tip of the screwdriver was broken, and the broken screwdriver tip got stuck in the screw head.After removing all the other screws, the surgeon scraped it with an air tome etc.And completed removing all the implants.There is no residue inside the body".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and is indeed broken.The device inspection showed that the cat# and lot# reported could be confirmed.The tip of the device was broken, due to clear torsional overload.Indeed, the torsion lines of the breakage were clearly visible, even to the naked eye.A microscope picture showed the torsion lines of the breakage even more clearly.Over torque can therefore be identified as the root cause for this case.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "during the removal operation of the proximal humerus plate of axos, the locking screw was hard and the tip of the screwdriver was broken, and the broken screwdriver tip got stuck in the screw head.After removing all the other screws, the surgeon scraped it with an air tome etc.And completed removing all the implants.There is no residue inside the body".

• Brand Name: SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKING SET
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11517743
• Report Number: 0008031020-2021-00092
• Device Sequence Number: 14414094
• Product Code: LXH
• UDI-Device Identifier: 07613327005028
• UDI-Public: 07613327005028
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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 Model Number: 702753
• Device Catalogue Number: 702753
• Device Lot Number: J03730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR