MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HOLDING SCREW T2 ANKLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-3203
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/26/2022
Type of Reportable Event	Serious Injury
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: "at the start of the medical procedure in this clinic, the bloody nail holding screw 1806-3203 (loaner) from the last surgery of the previous patient was still in the nail holding adapter 1806-3211.This was overlooked during the kit inspection, and a new nail holding screw was added instead.The instrument set was therefore hygienically not ok and could not be used for the surgery.Patient received unnecessary anesthesia.The surgery was cancelled and will be made up on monday (b)(6) 2022 under sterile hygienic conditions." additionally, it was reported; the procedure was extended however the length of the extension is unknown.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was returned but does not match the alleged failure.The received nail-holding screw shows no sign of any blood/dirt residue on the surface, usable marks are visible around the neck, and hitting marks are visible on the head area.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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.However, a local nc has been initiated to address the failure mode related to this complaint.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "at the start of the medical procedure in this clinic, the bloody nail holding screw 1806-3203 (loaner) from the last surgery of the previous patient was still in the nail holding adapter 1806-3211.This was overlooked during the kit inspection, and a new nail holding screw was added instead.The instrument set was therefore hygienically not ok and could not be used for the surgery.Patient received unnecessary anesthesia.The surgery was cancelled and will be made up on monday (b)(6) 2022 under sterile hygienic conditions." additionally, it was reported; the procedure was extended however the length of the extension is unknown.

• Brand Name: NAIL HOLDING SCREW T2 ANKLE
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15470888
• Report Number: 0009610622-2022-00441
• Device Sequence Number: 16862369
• Product Code: LXH
• UDI-Device Identifier: 04546540708458
• UDI-Public: 04546540708458
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1806-3203
• Device Catalogue Number: 18063203
• Device Lot Number: K0D56F8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown