MAUDE Adverse Event Report: STRYKER GMBH TIBIAL NAIL T2 ALPHA? TIBIA Ø9X330MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23410933S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device discarded at hospital.
Event or Problem Description
It was reported that the patient had primary surgery on (b)(6) 2023 to insert a tibial nail.The patient was a severely injured patient; the opposite leg had been amputated.The operated leg was also missing a lot of soft tissue, so surgeon scheduled to undergo surgery to transplant vascular tissue and skin at a later date.The initial surgery was successfully completed, but the day after the surgery, the surgeon informed sales rep that he wanted to perform a surgery to replace it with a shorter nail than implanted.The reason for wanting to replace the nail with a short nail was to make the defect as small as possible for the soft tissue transplant surgery.Since the bone itself where the initial surgery was performed had been crushed and the opposite leg had already been amputated, there was no need to worry about leg length difference, so he decided it would be better to shorten the leg and performed the surgery to replace the nail.Revision surgery was performed on (b)(6) 2023.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device or x-rays were not available to confirm the revision, however, the issue is user preference related as indicated by the additional information.A device inspection was not possible since the affected device was not returned, however, a device inspection was not considered necessary.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 additional information received and admission of the operating surgeon that the nail revision (long nail to short) was planned to make the defect as small as possible for the soft tissue transplant surgery, it is safe to say the issue is due to user preference related.No allegations were made against the device.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the patient had primary surgery on (b)(6) 2023 to insert a tibial nail.The patient was a severely injured patient; the opposite leg had been amputated.The operated leg was also missing a lot of soft tissue, so surgeon scheduled to undergo surgery to transplant vascular tissue and skin at a later date.The initial surgery was successfully completed, but the day after the surgery, the surgeon informed sales rep that he wanted to perform a surgery to replace it with a shorter nail than implanted.The reason for wanting to replace the nail with a short nail was to make the defect as small as possible for the soft tissue transplant surgery.Since the bone itself where the initial surgery was performed had been crushed and the opposite leg had already been amputated, there was no need to worry about leg length difference, so he decided it would be better to shorten the leg and performed the surgery to replace the nail.Revision surgery was performed on (b)(6) 2023.

• Brand Name: TIBIAL NAIL T2 ALPHA? TIBIA Ø9X330MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 18272820
• Report Number: 0009610622-2023-00438
• Device Sequence Number: 7690972
• Product Code: HSB
• UDI-Device Identifier: 07613327290745
• UDI-Public: 07613327290745
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 23410933S
• Device Lot Number: K01BC50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male