MAUDE Adverse Event Report: STRYKER GMBH BASEPLATE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5572-2800
Medical Device Problem Code	Positioning Failure (1158)
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.
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.".
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 information received from rep 12/24/2020: 5 screws that were wasted (1 center screw and 4 peripherals) along with the baseplate that we had to switch out.When we took out the baseplate and screws that had already been used, the surgeon wanted brand new screws for everything.
Additional Manufacturer Narrative
Corrections: please refer to section b5, d9/h3 the product was returned and h6 (method, result and conclusion codes).The reported event could be confirmed, since the device was returned and showed one enlarged peripheral screw hole which could have explained that the surgeon was not able to lock the screw on the baseplate.The dimensional inspection of said peripheral screw hole could confirm that the diameter was above the 5.3 mm expected, and was instead 5.97mm.In a first microscope picture of the enlarged hole, some material deformation could be noted.A manufacturing issue was not possible since 100% of the screw holes of the baseplates using a go/no go pin, and the production of the screw holes is an automatized process.To confirm that again, the baseplate was sent for a deeper analysis to an external lab, which took more precise microscope pictures that confirmed that the material deformation that was noticed on the lips happened after manufacturing.The r&d team was also involved and explained that in the cases where a drill guide was not used, or misused during the surgery, a similar event could happen.Indeed the drill guide needs to be inserted in the baseplate properly, to hang below the "lip" of the peripheral holes.This positioning allows the drill guide to protect the material of the lip and avoid its deformation, which is most probably what happened in the reported case.This case can therefore be classified as user related.The root cause can be attributed to an improper use of the drill guide alongside the baseplate during the drilling phase.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 any further information is provided, the complaint report will be updated.

• Brand Name: BASEPLATE
• 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: 11152679
• Report Number: 0008031020-2021-00018
• Device Sequence Number: 14422730
• Product Code: KWS
• UDI-Device Identifier: 07613327098709
• UDI-Public: 07613327098709
• 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): 05/26/2021

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: 11/30/2025
• Device Model Number: 5572-2800
• Device Catalogue Number: 5572-2800
• Device Lot Number: PX5XMK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 05/26/2021
• 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