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

Model Number 1806-3211

Device Problem Residue After Decontamination (2325)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Manufacturer Narrative

The reported event could not be confirmed, since the device was returned but does not match the alleged failure.The received nail adapter shows no sign of any blood/dirt residue on the surface, usage marks are visible.The further device looks in good condition.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 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 8/29/22 under sterile hygienic conditions." additionally, it was reported; the procedure was extended however the length of the extension is unknown.

• Brand Name: NAIL ADAPTER T2 ANKLE
• Type of Device: 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: 15485978
• MDR Text Key: 300583993
• Report Number: 0009610622-2022-00442
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540708489
• UDI-Public: 04546540708489
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1806-3211
• Device Catalogue Number: 18063211
• Device Lot Number: K0C495B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention