MAUDE Adverse Event Report: STRYKER GMBH RADIAL BROACH ASSY, SIZE 2 RHEAD; ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS

Catalog Number 170952

Device Problems Break (1069); Connection Problem (2900)

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

Event Date 05/04/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

While doing saw bones lab the broach broke at the connection between handle and tapered broach end.

Manufacturer Narrative

The reported event that a radial broach assy, size 2 rhead was alleged of breakage during surgery could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was most likely caused by improper inspection and functional testing of the device before usage.As stated in stryker¿s ¿instructions for cleaning, sterilization, inspection and maintenance¿, this is the best way of determining the end of serviceable life for the medical instrument.The device inspection revealed the following: the breakage surface was analysed.Its wavy trend reveals evident instantaneous zones.The fatigue zone could be identified as well.The device at issue underwent repeated stresses which resulted in fatigue breakage.A review of the device history was not possible.Any design, manufacturing and material issue can be excluded as a root cause of the event, though.Indeed, since it is known that the device at issue has been on the market for over 10 years, it is guaranteed that it has fulfilled its function.Stryker trauma & extremities typically does not specify the maximum number of uses appropriate for re-usable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.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.The instructions for cleaning, sterilization, inspection and maintenance (ot-rg-1 rev 3_l24002000 cleaning guide) were reviewed: ''stryker trauma & extremities typically does not specify the maximum number of uses appropriate for re-usable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.''.

Event Description

While doing saw bones lab the broach broke at the connection between handle and tapered broach end.

• Brand Name: RADIAL BROACH ASSY, SIZE 2 RHEAD
• Type of Device: ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5682426
• MDR Text Key: 46904029
• Report Number: 0008031020-2016-00271
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023604
• 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: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170952
• Device Lot Number: 09060001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2017
• 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