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

Model Number	1806-0325
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported the depth gauge was broken while measuring with the t2 depth gauge long to insert the distal locking screw.It was as if the thin tip had come loose from the thicker part in front of it.The broken part was not retrieved from the patient's body.
Event or Problem Description
It was reported the depth gauge was broken while measuring with the t2 depth gauge long to insert the distal locking screw.It was as if the thin tip had come loose from the thicker part in front of it.The broken part was not retrieved from the patient's body.
Additional Manufacturer Narrative
Please note correction to d9/h3; the device was discarded and h6 device code.The reported event could be not confirmed since the device was not returned for evaluation.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More information as well as the affected device must be available in order to determine the exact root cause of the issue.If the device is returned or any additional information is provided, the investigation will be reassessed.H3 other text : device discarded by the hospital.

• Brand Name: SCREW GAUGE, LONG T2 FEMUR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12459276
• Report Number: 0009610622-2021-00686
• Device Sequence Number: 1194306
• Product Code: LXH
• UDI-Device Identifier: 04546540196408
• UDI-Public: 04546540196408
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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