MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SOLID CR TIBIAL INSERT TRIAL SZ6 - 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530-T-616B

Device Problems Crack (1135); Fracture (1260); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The 6x16mm tibial insert trial cracked down the middle upon impaction during trial reduction.The #6 tibial baseplate trial was being held in place with two pins in the posterior fixation holes.The #6 cr femoral trial was in place on the femur.The insert impaction tool from the miscellaneous instrument tray was used to strike the insert into place in a flexed position.An alternative trial already available in the sterile field was used to continue the case.

Manufacturer Narrative

An event regarding crack/fracture involving a triathlon trial was reported.The event was confirmed.Method & results: -device evaluation and results: a material analysis has been performed.The report concluded: ¿the fracture occurred in fast fracture through the center of the device.The origin was found to be inside the material at the interface between the first and second injection molding shots.¿ -medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: the event was confirmed.The parts are injection molded by mack medical.Due to reports of cracks, sample parts were pulled from fg for evaluation.Lack of fusion areas were observed between the first and second shots of the two-shot trials.The reported device has been identified to be in the scope of an internal non conformance for the reported failure mode.

Event Description

The 6 x 16 mm tibial insert trial cracked down the middle upon impaction during trial reduction.The #6 tibial baseplate trial was being held in place with two pins in the posterior fixation holes.The #6 cr femoral trial was in place on the femur.The insert impaction tool from the miscellaneous instrument tray was used to strike the insert into place in a flexed position.An alternative trial already available in the sterile field was used to continue the case.

• Brand Name: TRIATHLON SOLID CR TIBIAL INSERT TRIAL SZ6 - 16MM
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5912440
• MDR Text Key: 54158826
• Report Number: 0002249697-2016-02779
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132624
• 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: 01/09/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 5530-T-616B
• Device Lot Number: KMASR5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• 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: 78 YR
• Patient Weight: 96