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	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/15/2019
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
Primary procedure, tibia im nail.It was reported that the t2 self retaining screwdriver broke during surgery.After cleaning, the tip that retains the screw was found missing (the tip was in place prior to cleaning, rep confirmed no pieces of the instrument remain in the patient).Rep confirmed that no further information will be released by the hospital or surgeon.Procedure was completed successfully with no adverse consequences or surgical delay reported.
Event or Problem Description
Primary procedure, tibia im nail.It was reported that the t2 self retaining screwdriver broke during surgery.After cleaning, the tip that retains the screw was found missing (the tip was in place prior to cleaning, rep confirmed no pieces of the instrument remain in the patient).Rep confirmed that no further information will be released by the hospital or surgeon.Procedure was completed successfully with no adverse consequences or surgical delay reported.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the returned device, screwdriver shows normal traces of use.The reported screwdriver was observed as broken.The moveable blade was found completely broken off at the level of the end of the slot (moveable blade was not returned).This small piece is the one that allows the locking mechanism of this screwdriver to work and hold on to the screw when locked.The breakage surface shows the typical 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¿.It could not be excluded that the device was pre-damaged in former surgeries.A process change was performed; the wch coating was removed to prevent breakages of the moveable blade.The returned screwdriver manufacturing date pre-dates the process change.Furthermore, it is recommended that the screwdriver shall be treated with an appropriate instrument spray after every usage.A review of the device history for the returned lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.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.If any further information is provided, the complaint report will be updated.

• 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: 9165925
• Report Number: 0009610622-2019-00859
• Device Sequence Number: 469784
• 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): 12/17/2019

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: KMW350802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/15/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 12/17/2019
• 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