MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNIVERSAL ROD T2 FEMUR 9 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
After removing t2gtn, the end cap could be removed by the usual procedure, but the surgeon could not pull the nail out with soft tissue or callus, and tried to remove it with the conical extractor (18066171), but the inserted angle seemed bad, and the tip was damaged.In this case, it was replaced with t2alphagt at the pseudo joint after t2gtn.After removing the nail, reaming was done up to 15 mm and insert a 14 mm diameter nail.However, the surgeon attempted to remove it in the middle because the nail could not be inserted.The surgeon tried to attach the universal rod and remove the nail, but the nail did not come out at all, and when the surgeon was operating it with a hammer several times, the surgeon broke the thread part of the universal rod.The surgeon couldn't pull out the nail, so he could expand the inside of the medullary canal with k-wire, and managed to pull out the nail using the universal rod at the hospital.The, he was able to ream up to 16 mm again and insert a nail.When the strike plate was attached to the tip of the universal rod, the tip of the universal rod was damaged and left inside the strike plate.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the threads of the universal rod were found to be damaged, thus a normal weakened structural integrity due to repeated reprocessing cycles is considered possible.A review of the device history for the reported lot did not indicate any abnormalities.No indications of 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 breakage of universal rod happened due to application of excessive forces by the user with the help of hammer.It is stated in event description that ¿when the surgeon was operating it with a hammer several times, the surgeon broke the thread part of the universal rod¿.The labeling supports it by stating ¿use instruments/implants as described in this operative technique to avoid damage to instruments/implants or bone and soft tissue.¿ and ¿stryker offers a universal implant extraction set that is not compatible with the t2 alpha femoral / tibia nail.Use of the t2 alpha extraction shaft is required for removal.The universal implant extraction shaft may be used for removal of imn screws or other internal fixation systems.¿.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
After removing t2gtn, the end cap could be removed by the usual procedure, but the surgeon could not pull the nail out with soft tissue or callus, and tried to remove it with the conical extractor (18066171), but the inserted angle seemed bad, and the tip was damaged.In this case, it was replaced with t2alphagt at the pseudo joint after t2gtn.After removing the nail, reaming was done up to 15 mm and insert a 14 mm diameter nail.However, the surgeon attempted to remove it in the middle because the nail could not be inserted.The surgeon tried to attach the universal rod and remove the nail, but the nail did not come out at all, and when the surgeon was operating it with a hammer several times, the surgeon broke the thread part of the universal rod.The surgeon couldn't pull out the nail, so he could expand the inside of the medullary canal with k-wire, and managed to pull out the nail using the universal rod at the hospital.The, he was able to ream up to 16 mm again and insert a nail.When the strike plate was attached to the tip of the universal rod, the tip of the universal rod was damaged and left inside the strike plate.

• Brand Name: UNIVERSAL ROD T2 FEMUR 9 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 10268028
• Report Number: 0009610622-2020-00317
• Device Sequence Number: 3462788
• Product Code: LXH
• UDI-Device Identifier: 04546540196019
• UDI-Public: 04546540196019
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

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: 1806-0110
• Device Catalogue Number: 18060110
• Device Lot Number: K797553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR