MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.0MM TAPERED ROUTER; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5407FA3030
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device evaluated by manufacturer? awaiting device return.
Event or Problem Description
It was reported that during a lumbar laminectomy, the drill stalled and the dura was torn with the router.It was also reported that there was a five minute delay while the surgeon repaired the dura.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
The device was not returned for investigation.The quality investigation is complete.Device not returned.
Event or Problem Description
It was reported that during a lumbar laminectomy, the drill stalled and the dura was torn with the router.It was also reported that there was a five minute delay while the surgeon repaired the dura.It was further reported that the procedure was completed successfully.

• Brand Name: 3.0MM TAPERED ROUTER
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9272907
• Report Number: 0001811755-2019-03642
• Device Sequence Number: 13864514
• Product Code: HBE
• UDI-Device Identifier: 07613327096736
• UDI-Public: 07613327096736
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K143399
• 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): 12/02/2019

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 Catalogue Number: 5407FA3030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5407300000 SN(B)(4); 5407FA3000 SN(B)(4)
• Outcome Attributed to Adverse Event: Required Intervention