MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HANDLE T2 TIBIA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-1002
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2022
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: "the incident occurred in the operating room on (b)(6) 2022 and concerned the placement of a t2 tibial nail.After the nail was placed, it was impossible to remove the nail ancillary.The fixation screw assembly, tibia nail handle and nail seized.The nail had to be removed from the patient (with the handle still present at the end) and another one had to be inserted (smaller size, as there is only one of each size) using the second box of ancillary equipment present in the operating room.The operation ended well for the patient, but the procedure was lengthened and the nail placed was slightly shorter than initially planned.The nail - nail handle disassembly was performed after the procedure: the nail tip broke off and so did the following ancillaries due to the fact that they had to be forced out due to seizure.The explanted nail, the gimbal wrench, the handle and the fixation screw were recovered and decontaminated.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the outer surface of the nail handle shows signs of usage.Both the pegs are completely broken off may be due to repetitive and forward application of high torsional load.The overall breakage pattern reveals brittle fracture most likely due to a combination of high torsional and bending load.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to a user-related issue.The failure was most likely caused due to an oblique insertion/cross threading/some debris inside the hole.The investigation of the parts involved indicates that it is likely that the observed issue of seizing of the nail holding screw is possible, if an unfavorable constellation of several dimensions (extreme value and specific direction) meet when assembling the devices.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "the incident occurred in the operating room on (b)(6) 2022 and concerned the placement of a t2 tibial nail.After the nail was placed, it was impossible to remove the nail ancillary.The fixation screw assembly, tibia nail handle and nail seized.The nail had to be removed from the patient (with the handle still present at the end) and another one had to be inserted (smaller size, as there is only one of each size) using the second box of ancillary equipment present in the operating room.The operation ended well for the patient, but the procedure was lengthened and the nail placed was slightly shorter than initially planned.The nail - nail handle disassembly was performed after the procedure: the nail tip broke off and so did the following ancillaries due to the fact that they had to be forced out due to seizure.The explanted nail, the gimbal wrench, the handle and the fixation screw were recovered and decontaminated.".

• Brand Name: NAIL HANDLE T2 TIBIA
• 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: 15354732
• Report Number: 0009610622-2022-00419
• Device Sequence Number: 12409482
• Product Code: LXH
• UDI-Device Identifier: 04546540196538
• UDI-Public: 04546540196538
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: Health Professional
• Device Model Number: 1806-1002
• Device Catalogue Number: 18061002
• Device Lot Number: KHI008256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 09/05/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2020
• 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