MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO SMALL GAMMA3 Ø4.2X300MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13203042
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "damaged drill bit inside the ankle joint between the shaft and the bone at the time of drilling.".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The received drill is broken from the tip and the broken fragment was not returned for evaluation.Broken surface of the drill is relatively smooth having a shear cavity without any plastic deformation which indicates towards a brittle failure of the drill due to mechanical overload leading to sudden breakage.Some portions in the microscopic image of the fractured surface are rubbed shiny which indicates usage of the drill even after breakage or failure.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 the above investigation the root cause can be attributed to user related as breakage happened due to mechanical overload leading to breakage.However, an nc was previously opened to address the recurring situation but no non conformity was observed in product and the nc was closed without any further corrective actions.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "damaged drill bit inside the ankle joint between the shaft and the bone at the time of drilling.".

• Brand Name: DRILL, AO SMALL GAMMA3 Ø4.2X300MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19997144
• Report Number: 0009610622-2024-00795
• Device Sequence Number: 4374501
• Product Code: LXH
• UDI-Device Identifier: 04546540377883
• UDI-Public: 04546540377883
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 11/15/2024

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: 13203042
• Device Lot Number: KU129138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2020
• 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: Female