MAUDE Adverse Event Report: STRYKER GMBH RADIO CAPITELLUM, TRIAL, LEFT SM UNI-ELBOW; IMPLANT

Catalog Number 4103155

Device Problems Compatibility Problem (2960); Protective Measures Problem (3015)

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

Event Date 04/24/2016

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

During a cadaver lab dissection course and demonstration of the uni-elbow doctor was having issues with implanting the capitellum implant to fit the cuts of the distal humerus.Doctor came to assist and troubleshoot.We removed the implant and reproached the canal.Implanted again and it still did not fit the cuts.Doctor then took out the trial and held it up against the implant to note that the canal and stem of the implant did not match.He believes it is a design flaw.

Manufacturer Narrative

This device is concomitant and did not contribute to the reported failure.This investigation is therefore closed in phase 1.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

Event Description

During a cadaver lab dissection course and demonstration of the uni-elbow doctor was having issues with implanting the capitellum implant to fit the cuts of the distal humerus.Doctor came to assist and troubleshoot.We removed the implant and rebroached the canal.Implanted again and it still did not fit the cuts.Doctor then took out the trial and held it up against the implant to note that the canal and stem of the implant did not match.He believes it is a design flaw.

• Brand Name: RADIO CAPITELLUM, TRIAL, LEFT SM UNI-ELBOW
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; postfach; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5660976
• MDR Text Key: 45981892
• Report Number: 0008031020-2016-00264
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4103155
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: No
• 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