MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON TIBIAL TEMPLATES W/HEADED FIXATION PINS PER FILE K2882; INSTRUMENT

Catalog Number I-K2882TT00

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

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

Event Date 06/15/2015

Event Type  malfunction  

Event Description

While templating the tibia, keel was placed, after punch, template was removed by using a mallet on the underside of the shaft to release the template, breaking the anterior reference point.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding fracture involving a specialty tibial template was reported.The event was confirmed.Method & results: device evaluation and results: evaluation of the device confirmed the event.The material analysis concluded the device fractured due to overload.Medical records received and evaluation: not performed as no medical records were received.Device history review: there were no reported discrepancies.Complaint history review: there have been no other events for the referenced lot.Conclusions: the investigation concluded the device fractured due to overload stress.There is no indication nor evidence at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.

Event Description

While templating the tibia, keel was placed, after punch, template was removed by using a mallet on the underside of the shaft to release the template, breaking the anterior reference point.

• Brand Name: SPECIALTY TRIATHLON TIBIAL TEMPLATES W/HEADED FIXATION PINS PER FILE K2882
• Type of Device: INSTRUMENT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4901780
• MDR Text Key: 21551187
• Report Number: 0002249697-2015-02267
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2015

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: I-K2882TT00
• Device Lot Number: AP5H2P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 07/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2010
• 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