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

Model Number 2341-1037S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); Non-union Bone Fracture (2369); Implant Pain (4561)

Event Date 05/04/2022

Event Type  Injury  

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 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".

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 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
• Type of Device: 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
• MDR Text Key: 296287648
• Report Number: 0009610622-2022-00332
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327291186
• UDI-Public: 07613327291186
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 106 KG