MAUDE Adverse Event Report: STRYKER GMBH WASHER FOR SCREWS: Ø4.5/6.5/8.0MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Model Number 390016S

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2017

Event Type  malfunction  

Manufacturer Narrative

The reported event that washer for screws: ø4.5/6.5/8.0mm was alleged of issue s-41 (poor fixation) could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the labeling did not indicate any abnormalities.As clearly stated in ifu, 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.Based on investigation, the root cause could be attributed to a user related issue.The failure could have been caused due to wrong selection of screw or washer.However, please bear in mind that more detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.A review of the device history record for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.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.Product discarded.

Event Description

The customer reported that the surgeon, was using a 6.5 asnos screw and the head of the screw went straight through the washer.The case was completed successfully, although the screw was left without a washer.There was a few minutes delay while the screw was removed from the patient - this was an asnis 6.5 hip screw done percutaneously so difficult to retrieve from small incision.

• Brand Name: WASHER FOR SCREWS: Ø4.5/6.5/8.0MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7015146
• MDR Text Key: 92217580
• Report Number: 0008031020-2017-00642
• Device Sequence Number: 1
• Product Code: KTW
• UDI-Device Identifier: 04546540430298
• UDI-Public: (01)04546540430298(17)220331(10)L08060
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K001614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 390016S
• Device Catalogue Number: 390016S
• Device Lot Number: L08060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other