MAUDE Adverse Event Report: STRYKER GMBH CANNULATED T25 SCREWDRIVER SHAFT AUTOFIX 6.5

Catalog Number	9010048
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported by the company rep: during multiple cases using the 6.5 autofix loan kit where the k-wires provided (or ones of the same size 1.8mm) are not fitting through the autofix instrumentation, this has happened in multiple instrument sets.The issue was discovered initially in a case resulting in another kit being used and extended under anesthetic time.Surgery was completed by using competitor kit.Inquiry pi 3697784 - event date 07/19/2024 friday.Case completed with competitor kit.1 out of 4.
Additional Manufacturer Narrative
Based on additional information received, it was confirmed that the involved device was added as a complaint in our system in error.The event only involved one faulty screwdriver, reported in mfr report ref# 0008031020-2024-00320.Therefore, this mdr report will be cancelled as non-reportable.
Event or Problem Description
As reported by the company rep: during multiple cases using the 6.5 autofix loan kit where the k-wires provided (or ones of the same size 1.8mm) are not fitting through the autofix instrumentation, this has happened in multiple instrument sets.The issue was discovered initially in a case resulting in another kit being used and extended under anesthetic time.Surgery was completed by using competitor kit.Inquiry pi (b)(6) - event date (b)(6) 2024 friday.Case completed with competitor kit.1 out of 4.

• Brand Name: CANNULATED T25 SCREWDRIVER SHAFT AUTOFIX 6.5
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19997082
• Report Number: 0008031020-2024-00322
• Device Sequence Number: 14538840
• Product Code: HXX
• UDI-Device Identifier: 03700586902947
• UDI-Public: 03700586902947
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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: 9010048
• Device Lot Number: Y1282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown