MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 40MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5572-4540
Medical Device Problem Codes	Material Invagination (1336); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.".
Additional 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 or Problem 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.".

• Brand Name: 4.5MM PERIPHERAL SCREW - 40MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11152677
• Report Number: 0008031020-2021-00020
• Device Sequence Number: 3878843
• Product Code: KWS
• UDI-Device Identifier: 07613327098778
• UDI-Public: 07613327098778
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: 5572-4540
• Device Catalogue Number: 5572-4540
• Device Lot Number: 106TY2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR