MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PRECISION THIN (9.0 X 0.38 X 25.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	2296003111
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
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 testing at the hospital.The blade broke.This event did not occur, during a surgical procedure.No patient involvement or adverse consequences were reported.
Additional Manufacturer Narrative
D4: added lot number and catalog number.H2: received device catalog and lot number.H2: device not returned for evaluation.H6: the quality investigation is complete.
Event or Problem Description
It was reported that during testing at the hospital, the blade broke.This event did not occur during a surgical procedure; no patient involvement or adverse consequences were reported.

• Brand Name: PRECISION THIN (9.0 X 0.38 X 25.0MM)
• 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: 19825830
• Report Number: 3015967359-2024-01594
• Device Sequence Number: 12928047
• Product Code: GFA
• UDI-Device Identifier: 04546540046499
• UDI-Public: (01)04546540046499(17)290301(10)24074077
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 12/05/2024

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: Health Professional
• Device Catalogue Number: 2296003111
• Device Lot Number: 24074077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2024
• 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
• Patient Sex: Unknown