MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER AXSOS T15 4.0MM LOCKING SET; PLATE, FIXATION, BONE

Catalog Number	702747
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.
Event or Problem Description
Product was returned to stryker (b)(4) technical services for repair along with other products.The product was noticed to have a broken/sheared bit at the screwdriver tip.
Additional Manufacturer Narrative
The reported event that screwdriver axsos t15 4.0mm locking set was alleged of 'breakage during surgery & instrument breakage identified out of surgery' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event such as the lot number, the reprocessing steps used to clean the device, as well as the affected device must be available in order to determine the root cause of the complaint event.Nevertheless, based on complaint history review, some possible root causes are, but are not limited to: normal wear or fatigue linked to the extensive usage of the device.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.See appendix 2 for further details " the application of an overtorque on the device, which could have caused its failure.As a reminder, the ifu states: "ensure that you are familiar with the intended uses, compatibility and correct handling of the instrument, which are described in the operative technique of the product system.Please remember that product systems may be subject to alterations that may affect the compatibility of the instrument with other instruments or with implants.For your information, avail yourself of the training courses and publications offered." an inadequate reprocessing of the device, which could have weakened the material and shortned its duration of usage.Please refer to the cleaning and sterilization guide.A review of the device history was not possible because the lot number was not communicated.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.
Event or Problem Description
Product was returned to stryker uk technical services for repair along with other products.The product was noticed to have a broken/sheared bit at the screwdriver tip.

• Brand Name: SCREWDRIVER AXSOS T15 4.0MM LOCKING SET
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7883154
• Report Number: 0008031020-2018-00607
• Device Sequence Number: 16766406
• Product Code: HRS
• UDI-Device Identifier: 07613327005011
• UDI-Public: 07613327005011
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K141121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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: Health Professional
• Device Catalogue Number: 702747
• Device Lot Number: U12688
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 11/16/2018
• 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