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

Catalog Number	18060233
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that, during gamma surgery, screw drivers were broken.Discovery was made upon inspection after the case.The surgery was completed successfully with approximately a one minute delay.No further information provided from the hospital or the surgeon.No adverse consequences were reported.
Additional Manufacturer Narrative
Correction: section d4 (lot #).The reported event could be confirmed.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.Inspection of the relevant dimensions was not possible due to the extent of damage.The breakage surface shows the typically structure of a brittle fracture, due to a bending overload.To prevent bending the screwdriver (sleeve) is laser-marked with the printing ¿do not lever¿.Referring to the very long period since manufacturing [manufactured between october 2007 and february 2009] the device has reached the end of its useful service-life and had fulfilled its tasks in former surgeries as intended, until the reported event, without problems reported.It could not be excluded that the device was pre-damaged in former surgeries.Based on the above observations the root cause of the reported event is not related to a deficiency of the device but is rather linked to improper handling by the user and has to be classified as misuse.
Event or Problem Description
It was reported that, during gamma surgery, screw drivers were broken.Discovery was made upon inspection after the case.The surgery was completed successfully with approximately a one minute delay.No further information provided from the hospital or the surgeon.No adverse consequences were reported.

• Brand Name: SCREWDRIVER, SELF-HOLDING, LONG 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: 8483033
• Report Number: 0009610622-2019-00142
• Device Sequence Number: 16626337
• Product Code: LXH
• UDI-Device Identifier: 04546540520425
• UDI-Public: 04546540520425
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/24/2019

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: 18060233
• Device Lot Number: KMW350703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: 03/23/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1