MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON MIS FULLY CAPTURED 4-IN-1 BLOCK SET; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	I-K2359CB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Primary procedure, right knee.It was reported that the weld broke on the posterior capture of the cutting block.The procedure was completed successfully with the device.All pieces were removed from the patient with no surgical delay.
Additional Manufacturer Narrative
Corrected data: device information updated.An event regarding crack/fracture involving a triathlon cutting block was reported.The event was confirmed through material analysis of the returned device.Method & results: product evaluation and results: visual inspection of the returned product indicated: multi directional scratches are visible on the product , these scratches are consistent with multiple uses.A fracture of the weld broke is visible on the posterior capture of the cutting block.The material analysis report revealed: one of the tabs fractured from the cutting block at both welds.The weld depth of the tab was measured and met the drawing requirement.Based on sem imaging, the tab fractured in overload.Eds showed the tab was consistent with 17-4 ph stainless steel alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: not performed as no medical records were provided for review.-product history review: indicated the device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the material analysis report revealed: one of the tabs fractured from the cutting block at both welds.The weld depth of the tab was measured and met the drawing requirement.Based on sem imaging, the tab fractured in overload.Eds showed the tab was consistent with 17-4 ph stainless steel alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.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
Primary procedure, right knee.It was reported that the weld broke on the posterior capture of the cutting block.The procedure was completed successfully with the device.All pieces were removed from the patient with no surgical delay.

• Brand Name: SPECIALTY TRIATHLON MIS FULLY CAPTURED 4-IN-1 BLOCK SET
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7718040
• Report Number: 0002249697-2018-02291
• Device Sequence Number: 11188319
• Product Code: MBH
• UDI-Device Identifier: 07613327242171
• UDI-Public: 07613327242171
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

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 Expiration Date: 05/31/2011
• Device Catalogue Number: I-K2359CB00
• Device Lot Number: F3M6727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR