MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SCREWDRIVER, SELF-HOLDING, EXTRA SHORT SCREWDRIVER, SELF-HOLDING 3.5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0203
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported by rep: "checking instrument before assembly post case and noticed tip of screwdriver was broken.The screwdriver was not used in surgery, so patient was not affected".
Event or Problem Description
As reported by rep: "checking instrument before assembly post case and noticed tip of screwdriver was broken.The screwdriver was not used in surgery, so patient was not affected".
Additional Manufacturer Narrative
The reported event that screwdriver, self-holding, extra short screwdriver, self-holding 3.5 mm was alleged of issue a (instruments: broken or deformed screwdriver) 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 as well as the affected device must be available in order to determine the root cause of the complaint event.The device inspection was not possible as the product was not returned for investigation.Stryker devices are inspected before being released for distribution, if any deviation would have been noticed, a nonconformance would have been raised.This is the first reported case with this lot number, the device can be therefore confirmed faultless prior the distribution.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that only use an instrument for its intended purpose.Improper use of instruments might lead to loss in function or usage.[¿].Always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry.The design of the instrument must not be modified in any way.¿ the cleaning and sterilization guide states that ¿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.¿ it also mentions that ¿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.¿ and that ¿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¿.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: SCREWDRIVER, SELF-HOLDING, EXTRA SHORT SCREWDRIVER, SELF-HOLDING 3.5 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7481130
• Report Number: 0009610622-2018-00195
• Device Sequence Number: 13781447
• Product Code: LXH
• UDI-Device Identifier: 04546540520418
• UDI-Public: (01)04546540520418
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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 Model Number: 1806-0203
• Device Catalogue Number: 18060203
• Device Lot Number: KMW35070
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 11/12/2018
• 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