MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PATELLA CLAMP; INSTRUMENT

Catalog Number 6541-3-600

Device Problems Material Deformation (2976); Material Integrity Problem (2978); Mechanics Altered (2984)

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

Event Date 06/04/2015

Event Type  malfunction  

Event Description

Clamp would not lock when squeezed fully.Surgeon had to hold pressure on handle while cement set up.

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 handle that did not stay locked involving a triathlon patella clamp was reported.The event was confirmed.Method & results: device evaluation and results: visual and functional analysis confirmed the reported event.Medical records received and evaluation: not performed as medical records were not provided for evaluation.Device history review: all products were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been other events for this lot.Conclusions: the investigation determined that the reported failure has been previously investigated.An ecn was implemented to correct the reported failure.The returned device was confirmed to be manufactured before the ecn.

Event Description

Clamp would not lock when squeezed fully.Surgeon had to hold pressure on handle while cement set up.

• Brand Name: PATELLA CLAMP
• 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: 4879078
• MDR Text Key: 19310362
• Report Number: 0002249697-2015-02147
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-3-600
• Device Lot Number: CXW01E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2005
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other