MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER HANDLE,REVOLVING/RIGID, AO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	45-85000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
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: "after the operation, in-hospital cleaner noticed that the screw of the revolving/rigid switching part of the screwdriver handle was missing after running water rinsing and ultrasonic cleaning.It is unclear at what point in time the screw was missing.However, when the sales rep asked the surgeon and assistant, they said that they would notice if the screw fell off during the surgery.Thus, the facility concluded that the screw was probably fallen off and was down to the sink during running water rinsing.".
Event or Problem Description
As reported: "after the operation, in-hospital cleaner noticed that the screw of the revolving/rigid switching part of the screwdriver handle was missing after running water rinsing and ultrasonic cleaning.It is unclear at what point in time the screw was missing.However, when the sales rep asked the surgeon and assistant, they said that they would notice if the screw fell off during the surgery.Thus, the facility concluded that the screw was probably fallen off and was down to the sink during running water rinsing.".
Additional Manufacturer Narrative
Please note the correction to h6 component code.The reported event could be confirmed based on the investigation performed.The device inspection revealed the following: the identification of the returned instrument was confirmed based on the catalog # and the lot # marked.A detached screw and a detached slider of the handle were also returned.Apart from the detached parts, no major sign of deformation or wear could be observed on the instrument surface.The detached screw and slider caused the screwdriver handle to be loose.Due to the nature of the complaint, a functional inspection was not considered necessary, as it could be observed that the functionality of the device could not be fully given anymore.During manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.Due to the lack of more detailed information it was not possible to determine the root cause of the reported event.An unintended usage error could not be excluded, however, there was no clear evidence pointing towards it.There was no indication of manufacturing related issue.As a reminder, no complaint related to a similar event was reported for the same lot.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 more information is provided, the case will be reassessed.

• Brand Name: SCREWDRIVER HANDLE,REVOLVING/RIGID, AO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17218746
• Report Number: 0008031020-2023-00248
• Device Sequence Number: 2985352
• Product Code: LXH
• UDI-Device Identifier: 04546540540546
• UDI-Public: 04546540540546
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: E207315
• 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): 08/31/2023

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: Other
• Device Model Number: 45-85000
• Device Catalogue Number: 45-85000
• Device Lot Number: AK08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male