MAUDE Adverse Event Report: STRYKER GMBH OVERDRILL AO, DIA2.4MM X 122MM; PLATE, FIXATION, BONE

Model Number	703696
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Tip remains implanted, rest of device was disposed of.
Event or Problem Description
As reported: "a variax drill 2.4mm drill bit (703696) was used in a total hip case as a pilot hole for a suture passes.Apparently upon unerring the greater troch, the drill tip snapped off.The procedure was completed with drill bit tip remaining in patient.Drill bit shaft was removed from the field and disposed of.Drill bit tip was not removed as of surgeon recommendation.".
Event or Problem Description
As reported: "a variax drill 2.4mm drill bit (703696) was used in a total hip case as a pilot hole for a suture passes.Apparently upon unerring the greater troch, the drill tip snapped off.The procedure was completed with drill bit tip remaining in patient.Drill bit shaft was removed from the field and disposed of.Drill bit tip was not removed as of surgeon recommendation.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences 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.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Based on the provided information was the device used used in a total hip case.In this relation it can be mentioned that the overdrill with catalog # 703696 is intended to be used in conjunction with the variax 2 system, which is typically used for for internal fixation of bones or bone fragments.See operative technique for further details of the intended use.If more information is provided, the case will be reassessed.

• Brand Name: OVERDRILL AO, DIA2.4MM X 122MM
• Common Device Name: PLATE, FIXATION, BONE
• 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: 16048657
• Report Number: 0008031020-2022-00704
• Device Sequence Number: 20399792
• Product Code: HRS
• UDI-Device Identifier: 07613327069891
• UDI-Public: 07613327069891
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K132502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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: 703696
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 12/26/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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