MAUDE Adverse Event Report: STRYKER TRAUMA KIEL STEPDRILL FOR LAG SCREW T2 RECON; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-3025
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Sales rep reported that : "fitting a t2 recon nail, drill for cephalic screw.The drill bit broke into several pieces in the patient's femur.The largest parts were removed.Other boxes opened.Delay: 2hours".
Additional Manufacturer Narrative
Correction: section d9/h3, the device will not be returned.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.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿always treat the instrument carefully to avoid surface damage or alterations to the geometry.The design of the instrument must not be modified in any way.Before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other.During the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure.¿ 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.However, few of the probable causes of breakage of drill could be user error such as drilling error (drill bit missing the nail screw) or application of combined torsional and bending overload.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
Sales rep reported that : "fitting a t2 recon nail, drill for cephalic screw.The drill bit broke into several pieces in the patient's femur.The largest parts were removed.Other boxes opened.Delay : 2hours".

• Brand Name: STEPDRILL FOR LAG SCREW T2 RECON
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10532177
• Report Number: 0009610622-2020-00504
• Device Sequence Number: 3118393
• Product Code: LXH
• UDI-Device Identifier: 04546540414588
• UDI-Public: 04546540414588
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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 Model Number: 1806-3025
• Device Catalogue Number: 18063025
• Device Lot Number: KU75603
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 12/09/2020
• 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: Required Intervention