MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CMF CUSTOMIZED IMPLANT KIT LARGE; POLYTETRAFLUOROETHYLENE WITH CARBON FIBERS COMPOSITE IMPLANT MATERIAL.

Catalog Number 5444-0-300

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2015

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

It was reported by the company representative that a doctor stated during a case that part (b)(4) did not fit the patient dimensions correctly.The doctor used a bender and a cutter to make the part fit, and it was still implanted in the patient.There were no adverse consequences to report.

Manufacturer Narrative

An event regarding a size/fit issue involving a cmf customized implant kit was reported.The event was not confirmed.Method & results: -device evaluation and results: could not be performed as the subject device was not returned.-medical records received and evaluation: no patient medical records were available for review.-device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

It was reported by the company representative that a doctor stated during a case that part #54440300 did not fit the patient dimensions correctly.The doctor used a bender and a cutter to make the part fit, and it was still implanted in the patient.There were no adverse consequences to report.

• Brand Name: CMF CUSTOMIZED IMPLANT KIT LARGE
• Type of Device: POLYTETRAFLUOROETHYLENE WITH CARBON FIBERS COMPOSITE IMPLANT MATERIAL.
• 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: 5050109
• MDR Text Key: 25497382
• Report Number: 0002249697-2015-02903
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 5444-0-300
• Device Lot Number: K10135PM01MAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other