MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DRILL F. 20MM SCREWS 1.6X58MM, STRYKER SHAFT; INSTRUMENT

Model Number	60-16526
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported that the small end of the bit broke off in the patient's bone during the surgical procedure.There were no adverse consequences or revision surgery reported.
Additional Manufacturer Narrative
The reported event that the drill fractured intra-operatively could be confirmed.The visual inspection revealed that a part of the drill tip has been broken off.The breakage area and the remaining drill helix part shows a black color and heavy, plastic deformations.Furthermore, the cutting edges of the drill helix were heavily, plastically deformed / destroyed and shows a melted condition / very strong material bulging resulting from collision and friction with a metal object ¿ definitive no bone - in combination with a too high revolution speed.Also, the different occurred colours in the breakage area indicate too high temperature.Moreover, the breakage surface shows also strong material deformation and material bulging as well as a melted condition resulting from further drilling after the tip breakage.Finally, based on the investigation the root cause of the reported event was attributed to an inappropriate user handling.Indications for any material, manufacturing or design related issues were not found in the investigation.No preventive and/or corrective actions are deemed necessary at this time.
Event or Problem Description
It was reported that the small end of the bit broke off in the patients bone during the surgical procedure.There were no adverse consequences or revision surgery reported.

• Brand Name: DRILL F. 20MM SCREWS 1.6X58MM, STRYKER SHAFT
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 9450768
• Report Number: 0008010177-2019-00077
• Device Sequence Number: 2923023
• Product Code: HBE
• UDI-Device Identifier: 04546540731876
• UDI-Public: 04546540731876
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K070876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2020

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 Model Number: 60-16526
• Device Catalogue Number: 60-16526
• Device Lot Number: AK07/88
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1