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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH BASEPLATE CENTERING GUID E LEFT; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
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STRYKER GMBH BASEPLATE CENTERING GUID E LEFT; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS. Back to Search Results
Catalog Number 5901-1101
Device Problems Metal Shedding Debris (1804); Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/02/2018
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
During pilot wire insertion, metal burs on the centering guide caused the pilot wire to be scored, shooting metal shavings everywhere.Upon inspection, this was found to be caused by preexisting damage to the centering guide, and not related to improper technique from the surgeon.The surgeon used a magnetic suction tip and irrigated the site but did not see the need to radiographically confirm that all shavings were removed.Surgeon was able to freehand a second pilot wire without using the damaged centering guide.Surgical delay of 5-10 minutes was caused.Rep reported that x-rays, medical records, and further information are not available due to surgeon and hospital policy.
 
Event Description
During pilot wire insertion, metal burs on the centering guide caused the pilot wire to be scored, shooting metal shavings everywhere.Upon inspection, this was found to be caused by preexisting damage to the centering guide, and not related to improper technique from the surgeon.The surgeon used a magnetic suction tip and irrigated the site but did not see the need to radiographically confirm that all shavings were removed.Surgeon was able to freehand a second pilot wire without using the damaged centering guide.Surgical delay of 5-10 minutes was caused.Rep reported that x-rays, medical records, and further information are not available due to surgeon and hospital policy.
 
Manufacturer Narrative
The reported event that baseplate centering guid e left was alleged of issue (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: visual inspection: guide: general appearance in good condition, closer inspection revealed seized material inside the drill hole at both ends wire: material accumulation found at the tip, spiraled scratches apparent at the square connection; in between the shaft appeared being undamaged / engraving identified single use functional inspection the pilot wire did not pass the centering drill hole completely ¿ only a small part of the tip was visible at medial dimensional inspection guide: required pin did not pass the drill hole; drill hole partly ull ¿ material accumulation had decreased the initial diameter at the outlet wire: dimension was ohl at both ends ¿ material damage had increased the diameter; the shaft¿s undamaged area appeared being within specs; thus, initially manufactured acc.To specs.One of the components had become damaged due to insufficient use (insertion under misalignment).Consequently, using an undamaged component this one will inevitably become damaged as well.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 centering guide got damaged in the previous surgeries due to misalignment of pilot wire with guide during drilling of 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 in correct alignment; bending could lead to fretting and cold welding.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 hyperelastic properties may have the potential to reduce the occurrence of it.The brochure ¿instructions for cleaning, sterilization, inspection and maintenance¿ (l24002000) states that 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.If any further information is provided, the complaint report will be updated.
 
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Brand Name
BASEPLATE CENTERING GUID E LEFT
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 Key7226209
MDR Text Key98764513
Report Number0008031020-2018-00066
Device Sequence Number1
Product Code KWS
Combination Product (y/n)N
PMA/PMN Number
K130895
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number5901-1101
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2018
Date Manufacturer Received08/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age56 YR
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