MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 0.64 X 12.6MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0277096275
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: full udi is not available due to missing lot number.H6: a follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a procedure the blade broke.It was also reported that at the end of the surgery an x-ray was taken, and a broken piece of blade had remained in the patient.There was a clinically insignificant delay while the surgeon needed to reopen the incision and retrieve the blade fragment.It was further reported that there was no adverse consequences to the patient, and that the procedure was completed successfully.
Additional Manufacturer Narrative
D4: catalog and lot provided.H2: device evaluated.H6: the quality investigation is complete.
Event or Problem Description
No new information.

• Brand Name: RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 0.64 X 12.6MM)
• 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: 22320200
• Report Number: 3015967359-2025-01166
• Device Sequence Number: 8812369
• Product Code: GFA
• UDI-Device Identifier: 04546540051769
• UDI-Public: (01)04546540051769(17)960307(10)24211037
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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: 0277096275
• Device Lot Number: 24211037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown