MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL ALIGNMENT ANKLE CLAMP EM; INSTRUMENT

Catalog Number 6541-2-609

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

Triathlon ankle clamp cracked.Noticed after use.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Manufacturer Narrative

An event regarding a fractured triathlon tibial alignment ankle clamp was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the product was not returned for inspection.-medical records received and evaluation: not performed as there is no indication the event was related to patient factors -device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been other similar reported events for this lot id.Conclusions: the event could not be confirmed nor the root cause determined the device was not returned.The root cause was determined to be design.

Event Description

Triathlon ankle clamp cracked.Noticed after use.

• Brand Name: TIBIAL ALIGNMENT ANKLE CLAMP EM
• 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: 4496902
• MDR Text Key: 5440051
• Report Number: 0002249697-2015-00279
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/13/2015

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: 6541-2-609
• Device Lot Number: PCZY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2015
• Initial Date FDA Received: 02/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2012
• 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