MAUDE Adverse Event Report: STRYKER GMBH BASEPLATE CENTERING GUID E RIGHT; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number 5901-1100

Device Problems Break (1069); Device Inoperable (1663)

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

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The device was found to be broken and unusable, the tip was missing.

Manufacturer Narrative

The reported event that baseplate centering guide right was alleged of issue k-140 (assembling / disassembling of instruments with instruments) could be confirmed since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the pilot wire is completely stuck into the baseplate centering guide.The pilot wire is not straight anymore.Pilot wire has several scratches in the distal part of its length (just above its connection point with the baseplate centering guide), probably due to some tentative's to get it out.Its tip is also damaged/deformed.Baseplate centering guide is deformed on the edges and have corrosion at multiple locations on device surface showing signs of frequent use.Since the device was in use for 5 years (manufactured in 2013), and no complaint has been received previously it can be safely said that the device had fulfilled its tasks in former surgeries as intended during its release and initial usage period.A pre-damaging of the instrument in prior surgeries could not be excluded.Based on the observation the root cause can most likely be attributed to a user related issue.Most likely the pilot wire got cold welded due to friction based on bending forces during drilling the wire through the guide reception.This is a known reaction and already investigated in previous complaints.To guarantee a correct insertion it is necessary to insert the pilot wire through the guide with axial forces only; bending could lead to fretting and cold welding.Based on the given information the jamming of the pilot wire was caused by bending forces during drilling due to a user error.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Malfunction is usually found during functional check which is required per the brochure.If this event tends to happen often for certain users, the use of an alternative pilot wire (catalog# 5901-6072) with a softer material may have the potential to reduce the occurrence of it.If any further information is provided, the complaint report will be updated.

Event Description

The device was found to be broken and unusable, the tip was missing.

• Brand Name: BASEPLATE CENTERING GUID E RIGHT
• Type of Device: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7371122
• MDR Text Key: 103679296
• Report Number: 0008031020-2018-00205
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K130895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5901-1100
• Device Lot Number: P7S36
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other