MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO SMALL GAMMA3® Ø4.2 X 300 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-3042S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Retained by hospital.
Event or Problem Description
As reported: "surgeon did a head exchange due to possible infection." gamma3 drill was used in the primary surgery.
Event or Problem Description
As reported: "surgeon did a head exchange due to possible infection." gamma3 drill was used in the primary surgery.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned and no clinical or past medical history & no operative reports were provided.A review of the provided medical records and x-rays by a clinical consultant indicated: ¿event description states "head exchange due to possible infection".No patient demographics, no clinical or past medical history, no operative reports and no laboratory findings offered.No confirmation of the event description is possible due to insufficient information.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.More detailed information about the complaint event as well as the affected device, including pathology reports, operative reports, progress notes must be available to find the exact root cause of the event.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL, AO SMALL GAMMA3® Ø4.2 X 300 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9485571
• Report Number: 0009610622-2019-00971
• Device Sequence Number: 2079929
• Product Code: LXH
• UDI-Device Identifier: 04546540377890
• UDI-Public: 04546540377890
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 1320-3042S
• Device Catalogue Number: 13203042S
• Device Lot Number: K08CB36
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/26/2020
• 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
• Patient Age: 69 YR