MAUDE Adverse Event Report: STRYKER TRAUMA KIEL T2 FE RETRO NAIL LNG D9XL380; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2339-0938S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that a t2 alpha retrograde and axsos distal lateral femur plate failed resulting in a revision.
Additional Manufacturer Narrative
Please note the corrections to d1, d4 catalog # and d4 lot #.Please also note the correction to d9/h3 as the device was not returned for evaluation.The reported event could be confirmed, since nail breakage was confirmed on provided x-ray copies.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.In the case presented a 59 year-old male patient; 173 cm / 81 kg had initially been treated with a t2alpha retrograde nail which broke during a car accident - initial injury was sept 10 , 2020.He was revised with a t2alpha retrograde nail roughly a year ago, 1/7/22, ¿ which also broke, 1/5/23 was observed it was broken, and which is subject of above pi.Provided x-ray copies were sent to an health care practitioner for review.His comments in extracts: ¿the available x-ray copies revealed non-union after an implantation period of approx.1 year.A radiological metaphyseal gap of 2-3 cm, at the level of the broken locking screw hole, initially causing micro movements, and resulting in hypertrophic/partly atrophic non-union is a likely outcome.A nail, firmly connected to the implanted plate, could neither be confirmed nor excluded.¿.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by inappropriate bone healing contributed by suboptimal placement of the implant.H3 other text : device disposition unknown.
Event or Problem Description
It was reported that a t2 alpha retrograde and axsos distal lateral femur plate failed resulting in a revision.

• Brand Name: T2 FE RETRO NAIL LNG D9XL380
• 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: 16293562
• Report Number: 0009610622-2023-00024
• Device Sequence Number: 17755669
• Product Code: HSB
• UDI-Device Identifier: 07613327292480
• UDI-Public: 07613327292480
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 2339-0938S
• Device Catalogue Number: 23390938S
• Device Lot Number: K067682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 81 KG