MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON CAPTURED TIBIAL RESECTION GUIDE SET PER FILE K2084; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number I-K2084CT00

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2016

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

Dr.(b)(6) complained that tibial stylus is loose.It does not pop or lock into tibial cut block.Did not affect case and no adverse consequences.

Manufacturer Narrative

Reported event: an event regarding assembly issue involving a triathlon specialty tibial stylus was reported.The event was confirmed.Method & results: -device evaluation and results: functional inspection of the returned device confirmed the loose assembly.Dimensional inspection of the device determined that the diameter of the shaft of the body of the stylus did not meet specification.A wear inspection was performed and determined that longitudinal and circumferential wear patterns consistent with use against the mating body were observed.The root cause of the out of tolerance condition was consistent with wear that occurred during use.No material or manufacturing defects were observed on the surfaces examined.-medical records received and evaluation: not performed as no patient medical records were provided for review.-device history review: review of the device history records indicates the devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: the investigation concluded that the loose fit of the assembly was due to the out of tolerance condition of the shaft of the body of the tibial stylus.The root cause of the out of tolerance condition is consistent with wear that occurred during use.The device was manufactured in 2006.Wear of an instrument is not uncommon after 10 years of use.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

Event Description

Dr.(b)(6) complained that tibial stylus is loose.It does not pop or lock into tibial cut block.Did not affect case and no adverse consequences.

• Brand Name: SPECIALTY TRIATHLON CAPTURED TIBIAL RESECTION GUIDE SET PER FILE K2084
• Type of Device: 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5490525
• MDR Text Key: 40021452
• Report Number: 0002249697-2016-00743
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: I-K2084CT00
• Device Lot Number: DVXMHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 132