MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CROWN DRILL T2 ICF; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 2358-3105

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

Device was not returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

Surgeon treated a chronic charcot foot in a medial column procedure and provided the following feedback: ¿crown drill and bone plug seemed intuitive but it was a little struggle.¿ additional info received: "the struggle with the crown drill / bone plug extractor was it was too big for the patient and fractured the proximal portion of the 1st met head.It did not alter the outcome of the case.".

• Brand Name: CROWN DRILL T2 ICF
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10576685
• MDR Text Key: 208301062
• Report Number: 0009610622-2020-00539
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613327346473
• UDI-Public: 07613327346473
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2358-3105
• Device Catalogue Number: 23583105
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other