MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON TS TRIAL CUTTING GUDE SIZE 6 RIGHT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	I-K3834CG6R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Not returned.
Event or Problem Description
It was reported that custom instruments were being used for the first time in a surgery for a revision of a failed total knee replacement for the right knee.It was reported that the trial was impacted using the femoral impactor with two light mallet blows and on the second impaction, the lateral posterior condyle of the trial implant fractured at the location of the augment cut slot.The damage to the trial was noticed immediately, and it was removed from the femoral canal, and femoral preparation was completed using the standard instrumentation.
Additional Manufacturer Narrative
Reported event an event regarding crack/fracture involving a triathlon trial was reported.The event was confirmed via product evaluation.Method & results -product evaluation and results: visual inspection: visual inspection of the returned device noted the following: device was returned in damaged condition.The condyle of the trial was broken off confirming the reported crack/fracture event.Dimensional inspection: the returned instrument was inspected by the mahwah metrology lab to measure the distance between cutting slots.Lab evaluation reported dimensions of the fractured instrument conformed to the print requirements.The evaluation results determined the manufacturing of the instrument was not a cause of the instrument failure.Material analysis: the trial was returned fractured at the condyle, the mixed mechanism fracture morphology was consistent with an overload fracture.Energy dispersive spectroscopy showed that the base material was consistent with a 17-4 stainless steel (fe-cr-ni-cu) alloy.The hardness was observed to be approximately 42 hrc, meeting the drawing requirement of 40 hrc minimum.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: no medical records were received for review with a clinical consultant.-product history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.¿ -complaint history review: there has been 1 other similar events for the lot referenced.Conclusions: device was returned in damaged condition.The condyle of the trial was broken off confirming the reported crack/fracture event.The returned instrument was inspected by the mahwah metrology lab to measure the distance between cutting slots.Lab evaluation reported dimensions of the fractured instrument conformed to the print requirements.The evaluation results determined the manufacturing of the instrument was not a cause of the instrument failure.The trial was returned fractured at the condyle, the mixed mechanism fracture morphology was consistent with an overload fracture.Energy dispersive spectroscopy showed that the base material was consistent with a 17-4 stainless steel (fe-cr-ni-cu) alloy.The hardness was observed to be approximately 42 hrc, meeting the drawing requirement of 40 hrc minimum.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.Nc was issued to evaluate the root cause of the event.The nc investigation determined that the distal augment cut slots, a custom feature of the specialty instrument compared to the standard product, was not appropriately evaluated through the specialty instrument design process.Specifically, the load carrying capacity design input/performance requirement was not defined during the development of the device.A product field action was issued to remove impacted product from the field.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that custom instruments were being used for the first time in a surgery for a revision of a failed total knee replacement for the right knee.It was reported that the trial was impacted using the femoral impactor with two light mallet blows and on the second impaction, the lateral posterior condyle of the trial implant fractured at the location of the augment cut slot.The damage to the trial was noticed immediately, and it was removed from the femoral canal, and femoral preparation was completed using the standard instrumentation.

• Brand Name: SPECIALTY TRIATHLON TS TRIAL CUTTING GUDE SIZE 6 RIGHT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10992516
• Report Number: 0002249697-2020-02651
• Device Sequence Number: 10920107
• Product Code: HRY
• UDI-Device Identifier: 07613327328592
• UDI-Public: 07613327328592
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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 Model Number: I-K3834CG6R
• Device Catalogue Number: I-K3834CG6R
• Device Lot Number: AP15C09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1379-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other