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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 40MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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STRYKER GMBH 4.5MM PERIPHERAL SCREW - 40MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Model Number 5572-4540
Device Problems Material Invagination (1336); Failure to Align (2522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2020
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
 
Event Description
As reported: "implanted baseplate and when putting in peripheral screws the screw went through the baseplate.The metal casting that holds the screw was deformed.We had to take it out and put in a new one.Patient and outcome were fine." the baseplate and 6 screws were wasted.There are no allegations against the wasted screws.Surgery was completed successfully with a delay of approximately 1 hour.".
 
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
As reported: "implanted baseplate and when putting in peripheral screws the screw went through the baseplate.The metal casting that holds the screw was deformed.We had to take it out and put in a new one.Patient and outcome were fine." the baseplate and 6 screws were wasted.There are no allegations against the wasted screws.Surgery was completed successfully with a delay of approximately 1 hour.".
 
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Brand Name
4.5MM PERIPHERAL SCREW - 40MM
Type of Device
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
MDR Report Key11152677
MDR Text Key227972775
Report Number0008031020-2021-00020
Device Sequence Number1
Product Code KWS
UDI-Device Identifier07613327098778
UDI-Public07613327098778
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 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5572-4540
Device Catalogue Number5572-4540
Device Lot Number106TY2
Was Device Available for Evaluation? No
Date Manufacturer Received03/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age61 YR
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