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 Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported, a primary procedure, right shoulder.It was reported that after impaction, the trial impinged and got stuck in the patient.The surgeon used a cocher to remove the trial, and two small fragments broke off of the trial.All pieces were removed from the patient (verified by visually inspecting the patient, pulse lavage, and reassembly of the device at the back table).Surgery was completed successfully with a delay of approximately 5-10 minutes.Rep reported that no further information is available.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the returned humeral insert trail is indeed broken off, wear is clearly visible.There are also some scratches and claw marks, as it was mentioned ¿surgeon used a cocher to remove the trial¿.Also noted that it was mentioned ¿that after impaction, the trial impinged and got stuck in the patient.¿ therefore we can determine that the surgeon encountered some difficulties during trailing and as the trail was stuck it could only be removed with extra force using a cocher.Which has lead to the breakage reported.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.Based on investigation, the root cause was attributed to be user related.The failure was caused by possible inadequate impaction as the trial got stuck in the patient during trailing.If any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported, a primary procedure, right shoulder.It was reported that after impaction, the trial impinged and got stuck in the patient.The surgeon used a cocher to remove the trial, and two small fragments broke off of the trial.All pieces were removed from the patient (verified by visually inspecting the patient, pulse lavage, and reassembly of the device at the back table).Surgery was completed successfully with a delay of approximately 5-10 minutes.Rep reported that no further information is available.

• 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 ; CH 2545
• MDR Report Key: 9477591
• Report Number: 0008031020-2019-02236
• Device Sequence Number: 16835203
• Product Code: KWS
• UDI-Device Identifier: 07613327100754
• UDI-Public: 07613327100754
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/05/2020

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: MAC10A09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR