MAUDE Adverse Event Report: STRYKER GMBH HUMERAL INSERT TRIAL - 3 2MM X 4MM STANDARD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5901-IS-3204
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported, primary procedure, left reverse tsa.It was reported that upon trying to reduce the shoulder, the crown of the humeral insert trial broke away from the rest of the trial.Patient was visually inspected to ensure all pieces were removed.Procedure completed with a constrained trial and was completed successfully with no delay.Rep confirmed that no further information is available.
Event or Problem Description
It was reported, primary procedure, left reverse tsa.It was reported that upon trying to reduce the shoulder, the crown of the humeral insert trial broke away from the rest of the trial.Patient was visually inspected to ensure all pieces were removed.Procedure completed with a constrained trial and was completed successfully with no delay.Rep confirmed that no further information is available.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the device is broken in two, at the junction between the flat part of the device, where the cat# and lot# of the device are laser marked, and the concave part.The fracture is probably due to a mishandling of the product (such as a hammering or such), as well as the normal wear of the device.Based on investigation, the root cause was attributed to be user as well as wear related.The failure was caused by an inadequate upkeep of the device combined with the normal wear of the 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: HUMERAL INSERT TRIAL - 3 2MM X 4MM STANDARD
• 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: 10359877
• Report Number: 0008031020-2020-02056
• Device Sequence Number: 3462551
• Product Code: KWS
• UDI-Device Identifier: 07613327100754
• UDI-Public: 07613327100754
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/22/2020

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 Model Number: 5901-IS-3204
• Device Catalogue Number: 5901-IS-3204
• Device Lot Number: A1EA6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR