MAUDE Adverse Event Report: STRYKER GMBH SCALED DRILL Ø2.5MM, AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	703966
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "patient was in operative room undergoing open reduction with internal fixation (orif) left acetabulum.In order to place pelvic screws, a long stryker 2.5mm drill bit was being used.During drill use, the tip of the drill bit broke off and this was immediately noticeable as fluoroscopy was used throughout the procedure as needed.Doctor attempted to remove the threads, but because they were unable to be removed easily, the drill tip was left in the bone in order to prevent further trauma to the bone.".
Event or Problem Description
As reported: "patient was in operative room undergoing open reduction with internal fixation (orif) left acetabulum.In order to place pelvic screws, a long stryker 2.5mm drill bit was being used.During drill use, the tip of the drill bit broke off and this was immediately noticeable as fluoroscopy was used throughout the procedure as needed.Doctor attempted to remove the threads, but because they were unable to be removed easily, the drill tip was left in the bone in order to prevent further trauma to the bone.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the drill is broken as complained.The device inspection revealed the following: the visual inspection has shown that the drill bit is broken apart at the crossover from the cutting flutes to the shaft.The fragment is missing as it was not possible to remove it.The turning test on the table has shown that the shaft is slightly bent at the forefront.There is plastic deformation at the breakage area visible and the remainder of the cutting edges is blunt.These damages could be an indication for a excessive metallic contact during use.The fracture face has the typical view of a ductile overload fracture, where the applied force does lead to permanent distortion with a subsequent fracture.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.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.Based on investigation, the root cause was attributed to a user related issue.The event was caused by a mechanical overload, most likely caused by an excessive metallic contact.Too much lateral stress may also have played a certain role as the shaft is slightly bent at the forefront.If more information is provided, the case will be reassessed.

• Brand Name: SCALED DRILL Ø2.5MM, AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 18652331
• Report Number: 0008031020-2024-00060
• Device Sequence Number: 7187255
• Product Code: LXH
• UDI-Device Identifier: 07613252719861
• UDI-Public: 07613252719861
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 703966
• Device Lot Number: KU143253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male