MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 1-3 KEEL PUNCH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	6541-2-013
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.H3 other text : device not returned.
Event or Problem Description
During a left total knee replacement during the keel punch part of the surgery the tibia split.All instrumentation was put together correctly.The guide tower was correct, the keel punch was correct and the baseplate was correct.Case went longer than usual.The surgeon didn't say anything negative, just wanted to report this.Additional info received 14-feb-2024, "the procedure was a primary implantation of stryker implants.Keel punch is the instrument used when the tibia split.The specific keep punch was one of the ones found in our mis 3-6 femoral and tibia prep tray.I wouldn't say it was too severe, but the split was big enough to need 2 screws.Screws were used to address the split bone.".

• Brand Name: SIZE 1-3 KEEL PUNCH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 18887264
• Report Number: 0002249697-2024-00386
• Device Sequence Number: 16880592
• Product Code: LXH
• UDI-Device Identifier: 07613327240986
• UDI-Public: 07613327240986
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: D112928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 6541-2-013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female