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

Model Number	5901-1116
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
As reported: "during last impaction of implant baseplate, we noticed impactor was fully extended without returning to normal width.The surgeon just loosened the bolt and pressed down on moveable tooth for extraction.Patient was not harmed, nor did this add any additional time to case.".
Event or Problem Description
As reported: "during last impaction of implant baseplate, we noticed impactor was fully extended without returning to normal width.The surgeon just loosened the bolt and pressed down on moveable tooth for extraction.Patient was not harmed, nor did this add any additional time to case.".
Additional Manufacturer Narrative
The initial report was submitted under fda registration number (b)(4) in error.The correct fda registration number is (b)(4).The reported event could be confirmed.The device inspection revealed the following: the device was returned and matches the event reported.The baseplate holder remains in an extended position, with the outer barrel outside of the axis of the device.The device deformation is most probably due to the application of a big force for an extended amount of time on the outer pin.This resulted in the plastic deformation of the material, which would not go back to its designed position.Based on investigation, the root cause was attributed to be user related.The failure was caused by the application of an inadequate force that resulted in a deformed device.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 investigation report will be updated.

• Brand Name: BASEPLATE HOLDER
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach NJ 2545 ; SZ 2545
• MDR Report Key: 10277747
• Report Number: 0002249697-2020-01459
• Device Sequence Number: 2297496
• Product Code: KWS
• UDI-Device Identifier: 07613327100273
• UDI-Public: 07613327100273
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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: 05/31/2023
• Device Model Number: 5901-1116
• Device Catalogue Number: 5901-1116
• Device Lot Number: P17N48
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other