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

Catalog Number 6541-2-609

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 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by sales rep, ankle clamp broke when removing from tibia.

Manufacturer Narrative

An event regarding a fractured triathlon tibial alignment ankle clamp was reported.The event was confirmed.Method & results: -devaluation and results: visual analysis confirmed the reported event.One of the device flippers fractured.The device was manufactured to the g revision.-medical records received and evaluation: not performed because there is no indication the event was related to patient factors -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 event for this lot id.Conclusions: the investigation concluded that the ankle clamp flipper broke from multiple overload conditions during use.A capa was raised to document root cause and corrections.Root cause was determined to be design related, the material selected was inadequate for designed use.A material design update was completed and the capa was closed on 10-mar-2014.

Event Description

It was reported by sales rep, ankle clamp broke when removing from tibia.

• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5081761
• MDR Text Key: 26261138
• Report Number: 0002249697-2015-03037
• 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: health professional,other
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Followup
• Report Date: 08/19/2015

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: PCZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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