MAUDE Adverse Event Report: STRYKER GMBH SR 4MM OFFSET HUMERAL HE AD TRIAL 52X23; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number 5901-E-5223

Device Problems Break (1069); Device Inoperable (1663); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device was received not decontaminated.

Event Description

Upon incoming inspection, it was noticed that the device was broken and unusable.Inner plastic peg was broken and missing.

Manufacturer Narrative

Corrections to concomitant medical products and device evaluated by mfr.The reported event that sr 4mm offset humeral he ad trial 52x23 was alleged of 'instruments - broken, deformed, worn or scratched' could be confirmed.More detailed information about the complaint event, such as if the device was used or not, if the device was impacted or not.Etc, as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on investigation history, some possible root causes are, but not limited to: - application of too much force by the healthcare professional during the use of the device.As a reminder, the ifu states: "ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.Before clinical use, the surgeon should thoroughly understand all aspects of the surgical procedure and limitations of the device.Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments." - inadequate storage conditions which could have lead to mixing heavy devices with lighter ones.Indeed, the cleaning and sterilization guide clearly reminds the user: "avoid mechanical damage, e.G.Do not mix heavy devices with delicate ones." - normal wear of the device after multiple years of use.The cleaning and sterilization guide states: "note: stryker trauma & extremities typically does not specify the maximum number of uses appropriate for re-usable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.For devices that may be impacted check that the device is not damaged to the extent that it malfunctions or that burrs have been produced that could damage tissues or surgical gloves.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.The device inspection revealed the following: the picture shows that one of the jaws of the three-jaw looking chuck is broken at its base, making the device unusable.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 the device is returned or if any additional information is provided, the investigation will be reassessed.Device not available.

Event Description

Upon incoming inspection it was noticed that the device was broken and unusable.Inner plastic peg was broken and missing.

• Brand Name: SR 4MM OFFSET HUMERAL HE AD TRIAL 52X23
• Type of Device: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7627541
• MDR Text Key: 112442306
• Report Number: 0008031020-2018-00474
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327099928
• UDI-Public: 07613327099928
• Combination Product (y/n): N
• PMA/PMN Number: K130895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 5901-E-5223
• Device Lot Number: MAC7K14
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 07/19/2018
• Supplement Dates FDA Received: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other