MAUDE Adverse Event Report: STRYKER GMBH SR HUMERAL HEAD TRIAL 52 X20; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	5901-S-5220
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Additional 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 not available.
Event or Problem Description
Upon incoming inspection it was noticed that the head trials were broken (total of 3).The items has been delivered to the decon lab.No further information available.
Event or Problem Description
Upon incoming inspection it was noticed that the head trials were broken (total of 3).The items has been delivered to the decon lab.No further information available.
Additional Manufacturer Narrative
The reported event that sr humeral head trial 52 x20 was alleged of 'instruments - broken, deformed, worn or scratched' could be confirmed.More detailed information about the complaint even, 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/ cleaning / sterilization / transport conditions which could have lead to mixing heavy devices with the trial heads, thus damaging them.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, since it has been used since 2011.As a reminder, 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.- inadequate use of the forked removal tool to disassemble the trial head, which could have damaged the trial head.The device inspection revealed the following: the pictures provided allow the confirmation of the failure more.Indeed the trial head of lot# mac6h08 is lacking 2 pegs of 3.The pegs of this device broke straight from the base.The trial head of lot# mac6k15 is lacking one peg, also broke from ist base on.Finally, lot# mac6h15 is lacking the 3 pegs, also broken according to the same failure mode as the other ones: from the base on.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: SR HUMERAL HEAD TRIAL 52 X20
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7506950
• Report Number: 0008031020-2018-00359
• Device Sequence Number: 1422369
• Product Code: LXH
• UDI-Device Identifier: 07613327100105
• UDI-Public: (01)07613327100105
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2018

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
• Operator of Device: Other
• Device Model Number: 5901-S-5220
• Device Catalogue Number: 5901-S-5220
• Device Lot Number: MAC6K15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 07/27/2018
• 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