MAUDE Adverse Event Report: STRYKER GMBH SCREW GAUGE, LONG T2 FEMUR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0325
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
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: "during surgery, the surgeon noticed a discrepancy between the length measurement using a scaled drill and the length gauge (difference approx.4mm).After checking in the sterilization department and comparison with two other references, this error appears to be confirmed and a comparatively longer length was determined.".
Additional Manufacturer Narrative
Please note correction to d3 (manufacturer entity).The reported event could be confirmed after deeper analysis with r&d, and the device was returned.Device inspection revealed the following: the received screw gauge is in good condition overall, there can be a difference of measurement simply due to the fact where the reference point for the measurement with the instrument is set.The difference can vary from the point of exit of the bone and the topology of the bone in that area while in scaled drill measures from the point where it is stopped.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.Based on the investigation, the root cause was attributed to a combination of user-related.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "during surgery, the surgeon noticed a discrepancy between the length measurement using a scaled drill and the length gauge (difference approx.4mm).After checking in the sterilization department and comparison with two other references, this error appears to be confirmed and a comparatively longer length was determined.".

• Brand Name: SCREW GAUGE, LONG T2 FEMUR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17025965
• Report Number: 0009610622-2023-00181
• Device Sequence Number: 20708090
• Product Code: LXH
• UDI-Device Identifier: 04546540196408
• UDI-Public: 04546540196408
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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: Health Professional
• Device Model Number: 1806-0325
• Device Catalogue Number: 18060325
• Device Lot Number: K411649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown