MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL T2 ALPHA? TIBIA Ø10X375MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2341-1037S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	05/04/2022
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.Device disposition unknown.
Event or Problem Description
As reported: "the patient is a (b)(6) male who previously underwent debridement and intramedullary fixation for an open tibial shaft fracture distally.The patient has been watched closely over the course of the past year.He did perform some healing callus around the fracture site, however, had some persistent pain.A ct scan revealed that there was a persistent fracture lucency consistent with nonunion.The patient was having discomfort.The patient was recommended treatment to include removal of his hardware and exchange nailing to a larger diameter nail with local reamed autograft.Resolved with sequelae: date of resolution (b)(6) 2022".
Additional Manufacturer Narrative
Please note the correction to d4 lot #.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history for the reported lot was not possible since the given data were the nail's dimension.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the formal investigation.A review of the labeling did not indicate any abnormalities.The patient is a 62-year-old male, 234 lbs / 66 inch = bmi 37 = severely obese, who previously underwent debridement and intramedullary fixation for an open tibial shaft v around the fracture site, however, had some persistent pain.A ct scan revealed that there was a persistent fracture lucency consistent with nonunion.The patient was having discomfort.The patient was recommended treatment to include removal of his hardware and exchange nailing to a larger diameter nail with local reamed autograft.The nail had been implanted on june 26, 2021 and was removed on june 17, 2022.After approx 1 year of implantation it was reported the bone had not healed.The event description did not complain any product deficiency like e.G.Nail or screw breakage.With received information the event was regarded as patient related.
Event or Problem Description
As reported: "the patient is a 62-year-old male who previously underwent debridement and intramedullary fixation for an open tibial shaft fracture distally.The patient has been watched closely over the course of the past year.He did perform some healing callus around the fracture site, however, had some persistent pain.A ct scan revealed that there was a persistent fracture lucency consistent with nonunion.The patient was having discomfort.The patient was recommended treatment to include removal of his hardware and exchange nailing to a larger diameter nail with local reamed autograft.Resolved with sequelae: date of resolution (b)(6).2022".

• Brand Name: TIBIAL NAIL T2 ALPHA? TIBIA Ø10X375MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 15070796
• Report Number: 0009610622-2022-00332
• Device Sequence Number: 17502632
• Product Code: HSB
• UDI-Device Identifier: 07613327291186
• UDI-Public: 07613327291186
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 2341-1037S
• Device Catalogue Number: 23411037S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 106 KG