MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2.5MM PRCSN MTCH HD, 13CM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	8450107525
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure, the nurse received a minor finger burn, no treatment was required for the burn.It was also reported that the bur broke in half.It was further reported that there was a one minute delay and the procedure was completed successfully.
Event or Problem Description
It was reported that during a surgical procedure, the nurse received a minor finger burn, no treatment was required for the burn.It was also reported that the bur broke in half.It was further reported that there was a one minute delay and the procedure was completed successfully.
Additional Manufacturer Narrative
Investigation results indicate that the bur broke due to issues with the associated attachment (b)(4).Excessive heat marks at the mid bearing location was observed on the returned bur.The associated mis 13cm curved attachment (b)(4).Upon disassembly, widespread internal corrosion was observed.The bur breakage occurred due to attachment mid bearing failure.The quality investigation is complete.

• Brand Name: 2.5MM PRCSN MTCH HD, 13CM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8175241
• Report Number: 0001811755-2018-02812
• Device Sequence Number: 16679854
• Product Code: HBE
• UDI-Device Identifier: 07613327097016
• UDI-Public: 07613327097016
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K143540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

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: No Information
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: 8450107525
• Device Lot Number: 18242017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 02/06/2019
• 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: 5407120900 SN (B)(4) ; 5407120950C SN (B)(4) ; 5407300000 SN (B)(4)