MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SET SCREWDRIVER, FLEXIBLE SHAFT GAMMA3® 4 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13200233
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2019
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
It was reported: the blue ring of the flexible screwdriver is missing.The device was ordered one month ago.Prior to the surgery, it was also determined that the locking bolt on the flexible screwdriver is not tight anymore.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications.The device inspection revealed the following: a new design version of the set screwdriver, flexible shaft gamma3® 4 mm could be verified.The current design of the set screwdriver does not contain a blue ring.The covered spring with blue silicone was part of a former design version (with a different catalog number) which is obsolete since september 2009.Furthermore, a c- ring at the intended position at the tip was identified as well.Based on provided images, the root cause was attributed to a user related issue.The event was not caused by a deficiency of the product; the root cause of the reported event is rather user related [lack of training ¿ lack of knowledge].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.
Event or Problem Description
It was reported: the blue ring of the flexible screwdriver is missing.The device was ordered one month ago.Prior to the surgery, it was also determined that the locking bolt on the flexible screwdriver is not tight anymore.

• Brand Name: SET SCREWDRIVER, FLEXIBLE SHAFT GAMMA3® 4 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: 9365462
• Report Number: 0009610622-2019-00936
• Device Sequence Number: 3231405
• Product Code: LXH
• UDI-Device Identifier: 04546540592545
• UDI-Public: 04546540592545
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2020

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: 13200233
• Device Lot Number: K07F5B1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1