MAUDE Adverse Event Report: STRYKER GMBH REUNION TSA - SR 4MM OFF SET HUMERAL HEAD 44X16; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5552-E-4416
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
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 is still implanted.
Event or Problem Description
It was reported that during a primary right shoulder procedure, the humeral head was opened and a powder substance was observed in the tray and on the implant.A second implant was opened and the same issue was observed.The first implant (lot xm3373) was cleaned off and implanted.Surgery was completed successfully with about a 3 minute delay.
Additional Manufacturer Narrative
Corrections: please refer to section h6 (method code, results code and conclusion code).The reported event could not be confirmed, since the device was not returned.However, based on the investigation of another complaint [.] on another lot, which was used by the same surgeon on the same surgery, some particles of what looks like dust could be found.A sample of the lot of another complaint [.] was taken out from stock, and the particles were gathered and sent to lab for analysis to determine its composition.The report states: "within the analysis, there was a nearly identical match from the spectrum of the debris to tyvek material, as well as a high match to the foam surrounding the implant.Since both tyvek and foam are considered part of the sterile barrier system, this would not be considered as ¿foreign material¿ to operations.Additionally, especially in regards to the tyvek, it is not within the current capabilities of operations to inspect for this type of debris once the unit is sealed.Since the sample that was tested was of the same family and was packaged on the same day as the lot from the original complaint, we have reason to believe that the white debris from the complaint is also likely to be of the same source." furthermore, a confirmation that the tyvek particles do not constitute any infection risk was confirmed from the microbiology team: "all sterilization process validations are performed by applying ¿overkill¿ (eo as well as gamma), therefore the products are sterile and all ¿residuals¿ are non-infective.The conclusion is that no risk of infection is existing.In regard of potential endotoxins, we also fulfill all required product testing/monitoring to assure the limit of <20eu/device no risk of ¿dead bacterial residuals¿ respectively endotoxins existing." as a conclusion, the particles present on the surface of the sterile implant do not constitute a risk of infection and are considered to be part of the sterile barrier.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.
Event or Problem Description
It was reported that during a primary right shoulder procedure, the humeral head was opened and a powder substance was observed in the tray and on the implant.A second implant was opened and the same issue was observed.The first implant (lot xm3373) was cleaned off and implanted.Surgery was completed successfully with about a 3 minute delay.

• Brand Name: REUNION TSA - SR 4MM OFF SET HUMERAL HEAD 44X16
• 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: 10946201
• Report Number: 0008031020-2020-02548
• Device Sequence Number: 2706021
• Product Code: KWS
• UDI-Device Identifier: 07613327097900
• UDI-Public: 07613327097900
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K103835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: 08/31/2022
• Device Model Number: 5552-E-4416
• Device Catalogue Number: 5552-E-4416
• Device Lot Number: XM3373
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR