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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
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
As reported: "breakage of drill tip.".
Event or Problem Description
As reported: "breakage of drill tip.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the drill bit is broken as complained.The device inspection revealed the following: the visual inspection has shown the drill bit is broken apart at the crossover from the cutting flutes to the shaft, the breakage is clean and no small fragments were generated.At the fracture initiation zone are two strong nicks at the corners visible.These damages are an indication for an excessive metallic contact, for example with the plate, during drilling.The breakage surface reveals typical characteristics of a brittle fracture i.E.Relatively smoother surface at the center than at the edges.Since the breakage was brittle (sudden) in nature, there is evidence of abrupt features especially by plateau on both sides of the fracture face.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 failure was caused by an excessive metallic contact which did lead to a mechanical overload.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: 17546748
• Report Number: 0008031020-2023-00306
• Device Sequence Number: 15058381
• Product Code: LXH
• UDI-Device Identifier: 07613252719861
• UDI-Public: 07613252719861
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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 Catalogue Number: 703966
• Device Lot Number: KU143130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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
• Patient Sex: Unknown