MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FREEHAND DRILL IMN INSTRUMENTS Ø4.2X185MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23514218S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was discarded.
Event or Problem Description
It was reported that, during a primary procedure on a left femur, the 180 drill broke going through the distal hole of the alpha gt nail.Procedure was completed successfully with no adverse consequences or surgical delay reported.

• Brand Name: FREEHAND DRILL IMN INSTRUMENTS Ø4.2X185MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8814456
• Report Number: 0009610622-2019-00553
• Device Sequence Number: 2838547
• Product Code: LXH
• UDI-Device Identifier: 07613327350319
• UDI-Public: 07613327350319
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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
• Report Date (Section B): 07/22/2019

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: 23514218S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1