MAUDE Adverse Event Report: STRYKER INSTRUMENTS-IRELAND ZYPHR DISP CRAN PERF LRG 14/11; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5100060001
Medical Device Problem Code	Failure to Auto Stop (2938)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: full udi is not available due to missing lot#.H6: a follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was also reported that there was medical intervention required to repair damaged tissue.We have requested more details on the reported delay.The procedure was reported to have been completed successfully.
Additional Manufacturer Narrative
H2: no delay time was provided, as per our requests.D4: full udi is not available due to missing lot#.H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was also reported that there was medical intervention required to repair damaged tissue.The procedure was completed successfully without a clinically significant delay.

• Brand Name: ZYPHR DISP CRAN PERF LRG 14/11
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill MI NA ; EI NA
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: kelsey barla ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 20368877
• Report Number: 3015967359-2024-01873
• Device Sequence Number: 3689181
• Product Code: HBF
• UDI-Device Identifier: 04546540716224
• UDI-Public: (01)04546540716224
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K082010
• 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): 02/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5100060001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown