MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT ASNIS III Ø2.0X150MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	702453
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.H3 other text : device disposition is unknown.
Event or Problem Description
The following maude report #mw5153440 was received and indicated the following: "patient scheduled for open reduction internal fixation right tibial tubercle fracture.The patella tendon was reinforced with semi-bennel sutures through the length of the patella tendon and passed through drill holes in the cortex of the distal tibia shaft.Drill bit broke and fragment of drill bit stuck in tibial cortex and was not retrievable.On (b)(6) 2024 patient scheduled for retrieval of broken drill bit.The drill bit tip was located and removed".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.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.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The following maude report #mw5153440 was received and indicated the following: "patient scheduled for open reduction internal fixation right tibial tubercle fracture.The patella tendon was reinforced with semi-bennel sutures through the length of the patella tendon and passed through drill holes in the cortex of the distal tibia shaft.Drill bit broke and fragment of drill bit stuck in tibial cortex and was not retrievable.On (b)(6) 2024 patient scheduled for retrieval of broken drill bit.The drill bit tip was located and removed".

• Brand Name: DRILL BIT ASNIS III Ø2.0X150MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 19235109
• Report Number: 0008031020-2024-00195
• Device Sequence Number: 5855943
• Product Code: HWE
• UDI-Device Identifier: 04546540112064
• UDI-Public: 04546540112064
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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: 702453
• Device Lot Number: W29434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown