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

Catalog Number 6541-2-609

Device Problems Break (1069); Fracture (1260); Nonstandard Device (1420); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 04/28/2014

Event Type  malfunction  

Event Description

Going through some of our trays and noticed clamp was broken on one side.No injuries occurred.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding a fractured triathlon tibial alignment ankle clamp was reported.The event was confirmed.Method & results: -device evaluation and results: visual analysis confirmed the reported event.One of the device flippers fractured.The device was manufactured to the f revision.-medical records received and evaluation: not performed because no patient information was provided.In addition, it is believed patient factors did not contribute to the reported event.-device history review: review of the device history records indicated 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 investigation concluded that the ankle clamp flipper broke from multiple overload conditions during use.The exact root cause cannot be determined at this time.Ncr and capa were opened to perform a root cause investigation.Root cause analysis will be documented in the capa file.

Event Description

Going through some of our trays and noticed clamp was broken on one side.No injuries occurred.

• 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: 4841470
• MDR Text Key: 5873372
• Report Number: 0002249697-2015-01899
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 6541-2-609
• Device Lot Number: NZN12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2249697-7/12/2013-008C
• Patient Sequence Number: 1
• Patient Outcome(s): Other