MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO, STERILE T2 HUMERUS Ø3,5X230 MM; SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS

Catalog Number	18063540S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
Event or Problem Description
Maude report (mw5082498) was received by stryker and reviewed for the following event: patient in surgery for total hip replacement.A stryker disposable drill bit broke off during the surgery.Broken piece retrieved and appeared to be intact.Surgeon aware.New drill bit obtained, and surgery continued.No harm to the patient.
Event or Problem Description
Maude report (mw5082498) was received by stryker and reviewed for the following event: patient in surgery for total hip replacement.A stryker disposable drill bit broke off during the surgery.Broken piece retrieved and appeared to be intact.Surgeon aware.New drill bit obtained, and surgery continued.No harm to the patient.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user to ¿avoid drilling into metal implants with bone drills.The implants could be critically weakened and break under load and the drill could be damaged¿.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.But possible causes of failure could be excessive axial force, excessive torque, contact with metal implant, misalignment or too hard/dense bone.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: DRILL, AO, STERILE T2 HUMERUS Ø3,5X230 MM
• Common Device Name: SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8359056
• Report Number: 0009610622-2019-00078
• Device Sequence Number: 11162517
• Product Code: HWE
• UDI-Device Identifier: 04546540196613
• UDI-Public: 04546540196613
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/18/2019

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: 18063540S
• Device Lot Number: K0C364C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other