MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PRECISION (13.0 X 0.51 X 39.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	2296033108
Medical Device Problem Codes	Break (1069); Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during service conducted at the manufacturer a blade flew out of the handpiece.This event did not occur during a surgical procedure; no delay or adverse consequences were reported.
Event or Problem Description
It was reported that during service conducted at the manufacturer a blade flew out of the handpiece.It was further reported that the blade broke due to being ejected.This event did not occur during a surgical procedure; no delay or adverse consequences were reported.
Additional Manufacturer Narrative
D4: full udi is unknown as the lot number was not reported.B5 & d9: the device was not returned for evaluation.H6: the quality investigation is complete.

• Brand Name: PRECISION (13.0 X 0.51 X 39.0MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• 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: 19773738
• Report Number: 3015967359-2024-01272
• Device Sequence Number: 20861829
• Product Code: GFA
• UDI-Device Identifier: 04546540046949
• UDI-Public: (01)04546540046949
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 12/03/2024

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: Other
• Device Catalogue Number: 2296033108
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/21/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 12/03/2024
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATALOG # 6400034000, SERIAL NO. (B)(6).
• Patient Sex: Unknown