MAUDE Adverse Event Report: STRYKER GMBH OVERDRILL AO, DIA2.4MM X 122MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	703696
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The company rep reported defective drill bit tips.
Additional Manufacturer Narrative
Corrections to d9 product return.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The company rep reported defective drill bit tips.
Event or Problem Description
The company rep reported defective drill bit tips.(b)(6) 2024 - additional information received: type of defect: deformation the procedure could be completed successfully without patient impact.Use of 2nd drill bit.
Additional Manufacturer Narrative
This report is generated as additional information has been provided by the customer.Therefore the method, clinical signs and health impact imdrf codes were updated accordingly.

• Brand Name: OVERDRILL AO, DIA2.4MM X 122MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20001110
• Report Number: 0008031020-2024-00323
• Device Sequence Number: 7319264
• Product Code: LXH
• UDI-Device Identifier: 07613327069891
• UDI-Public: 07613327069891
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2025

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: Other
• Device Catalogue Number: 703696
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 09/23/2024; 12/12/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 10/21/2024; 01/07/2025
• 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