MAUDE Adverse Event Report: STRYKER GMBH RADIO CAPITELLUM SMALL, LEFT; IMPLANT

Catalog Number 4100001

Device Problems Product Quality Problem (1506); Compatibility Problem (2960)

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 dr.(b)(6) 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.

Manufacturer Narrative

The reported incident that radio capitellum small, left was alleged of issue s-31 (no fitting) could be confirmed.Based on investigation, the root cause was attributed to a design related issue.The failure was caused by a non proper design.As a result of this investigation two different root causes were found: - angle cut: the trials show that the aperture angle between cuts is of 40 degrees.According to the current drawing and the previous versions this is correct angle.Nevertheless, the aperture angle of the implant is 45 degrees.In the current version is already corrected to 40 degrees, nevertheless, revision a of this implant shows a 45 degrees aperture angle.Thus, an implant manufactured according rev a with a trial manufactured with the concurrent revision (rev a as well) will not fit due to this angle difference.This was a known issue and, one month after implant rev a was launched, a change control was implemented to correct this angle difference.- tip thickness: the values of tip thickness are greater than they should, based in the drawing guidance.Nevertheless, revision a of the implant drawing shows that this values were considered not critical and therefore not considered as specification but only orientating values.Thus, would also be expected that a too thick tip, would have difficulties to fit in a small radium.The thickness of the tip become mandatory and considered as specification in revision c.Although it is expected that the implant will have difficulties to fit, both characteristics were already corrected in the past.The risk is into control limits and the volume of complaints received, in relation with this event, is low as well.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.

Event Description

During a cadaver lab dissection course and demonstration of the uni-elbow dr.Was having issues with implanting the capitellium 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 SMALL, LEFT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5660548
• MDR Text Key: 45982696
• Report Number: 0008031020-2016-00263
• 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: 4100001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2016
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other