MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP RECIPROCATING BLADE, TAPERED; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	5100337133
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.D4: full udi is not available due to missing information (unknown lot#).
Event or Problem Description
The blade ejected from the handpiece during a service evaluation at the manufacturer facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Event or Problem Description
The blade ejected from the handpiece during a service evaluation at the manufacturer facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Additional information: d1,d4; part number was provided by initial reporter.D4: full udi is not available due to missing lot number.Correction: this event is not reportable as the blade is concomitant to the handpiece.H6: the quality investigation is complete.

• Brand Name: RECIPROCATING BLADE, TAPERED
• 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: 20516193
• Report Number: 3015967359-2024-02241
• Device Sequence Number: 7082001
• Product Code: GFA
• UDI-Device Identifier: 04546540075413
• UDI-Public: 04546540075413
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• 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): 03/28/2025

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: 5100337133
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 03/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATALOG # 6400037000, SERIAL # (B)(6).
• Patient Sex: Unknown