MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4-6 KEEL PUNCH; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	6541-2-046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
The incident was during a mako left tka procedure, although may not be directly linked to stryker kit as there are many factors that could have caused it, such as sclerotic bone quality.A surgeon had used intra-incisional 4.0mm tibial pins, placed about 4-5cm below the plateau as recommended.The case proceeded as expected until the tibial pins were removed, and the tibial keel punch was used to prepare the tibia for an implant.Whilst impacting the keel punch, the tibia fractured through both holes in which the pins had previously been, and therefore a proximal tibial plate was required to be used as well as intra-operative x-raying in order to get the correct plate placement.This patient was still able to be discharged as a day case as far as i am aware however they were planned for a standard mako ps tka with a primary baseplate and ended up with a mako ps tka with universal baseplate and proximal tibial plate.Tourniquet was used.
Event or Problem Description
The incident was during a mako left tka procedure, although may not be directly linked to stryker kit as there are many factors that could have caused it, such as sclerotic bone quality.A surgeon had used intra-incisional 4.0mm tibial pins, placed about 4-5cm below the plateau as recommended.The case proceeded as expected until the tibial pins were removed, and the tibial keel punch was used to prepare the tibia for an implant.Whilst impacting the keel punch, the tibia fractured through both holes in which the pins had previously been, and therefore a proximal tibial plate was required to be used as well as intra-operative x-raying in order to get the correct plate placement.This patient was still able to be discharged as a day case as far as i am aware however they were planned for a standard mako ps tka with a primary baseplate and ended up with a mako ps tka with universal baseplate and proximal tibial plate.Tourniquet was used.
Additional Manufacturer Narrative
An event regarding intraoperative fracture involving a triathlon keel punch was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that a tibial fracture occurred during the use of the keel punch during surgery.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SIZE 4-6 KEEL PUNCH
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20114671
• Report Number: 0002249697-2024-01186
• Device Sequence Number: 7296722
• Product Code: MBH
• UDI-Device Identifier: 07613327240924
• UDI-Public: 07613327240924
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123166
• 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): 10/21/2024

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 Expiration Date: 04/30/2019
• Device Catalogue Number: 6541-2-046
• Device Lot Number: RD9E307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 08/31/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2014
• 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 Age: 64 YR
• Patient Sex: Male