MAUDE Adverse Event Report: STRYKER GMBH RECONSTRUCTION NAIL R2.0, TI, RIGHT T2 RECON Ø11X360 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18471136S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	06/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient that: "on (b)(6) 2021 i suffered a fracture of the femur in a skiing accident.This was surgically straightened at the hospital in lienz (austria) and the fracture was treated with a stryker nailing system (recon 11/360).After a long recovery (hospital, rehab and physiotherapy etc.) the above mentioned intramedullary nail broke on (b)(6) 2022.I felt very strong pain in the right thigh and hip.The fracture of the intramedullary nail was diagnosed at the hospital and it was removed during another surgery on (b)(6) 2022 and replaced by a new nail system.This was followed by another hospital stay and a new reha in bad tabarz is still pending.My new operation caused very severe pain, which continues to this day.According to the doctors, the situation will not change for the time being.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned.From the available operative notes, an expert medical opinion was requested:- "the x-ray is showing the situation after the revision with an inserted gamma nail.We can only see some callus formation and the distal screw holes of the removed recon nail.There seems to be a non-union, that has occurred.The nail has provided intramedullary stability for more than six months which is intended.If the bone does not unite within that time, the nail is going to fail as it happened here.If there would be the availability of the clinical situation with x-rays after the accident and postoperatively and with the failed device, without it, it is not possible to give a sound answer." 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 was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported by the patient that: "on (b)(6) 2021 i suffered a fracture of the femur in a skiing accident.This was surgically straightened at the hospital in lienz (austria) and the fracture was treated with a stryker nailing system (recon 11/360).After a long recovery (hospital, rehab and physiotherapy etc.) the above mentioned intramedullary nail broke on (b)(6) 2022.I felt very strong pain in the right thigh and hip.The fracture of the intramedullary nail was diagnosed at the hospital and it was removed during another surgery on (b)(6) 2022 and replaced by a new nail system.This was followed by another hospital stay and a new reha in bad tabarz is still pending.My new operation caused very severe pain, which continues to this day.According to the doctors, the situation will not change for the time being.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device, was not returned.From the available operative notes, an expert medical opinion was requested:- the x-ray is showing the situation after the revision with an inserted gamma nail.We can only see some callus formation and the distal screw holes of the removed recon nail.There seems to be a non-union, that has occurred.The nail has provided intramedullary stability for more than six months which is intended.If the bone does not unite within that time, the nail is going to fail as it happened here.If there would be the availability of the clinical situation with x-rays after the accident and postoperatively and with the failed device, then it is not possible to give a sound answer.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported by the patient that: "on (b)(6) 2021 i suffered a fracture of the femur in a skiing accident.This was surgically straightened at the hospital in lienz (austria) and the fracture was treated with a stryker nailing system (recon 11/360).After a long recovery (hospital, rehab and physiotherapy etc.) the above mentioned intramedullary nail broke on 6/29/2022.I felt very strong pain in the right thigh and hip.The fracture of the intramedullary nail was diagnosed at the hospital and it was removed during another surgery on (b)(6)2022 and replaced by a new nail system.This was followed by another hospital stay and a new reha in bad tabarz is still pending.My new operation caused very severe pain, which continues to this day.According to the doctors, the situation will not change for the time being.".

• Brand Name: RECONSTRUCTION NAIL R2.0, TI, RIGHT T2 RECON Ø11X360 MM X 125°
• 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: 15280304
• Report Number: 0009610622-2022-00397
• Device Sequence Number: 15245586
• Product Code: HSB
• UDI-Device Identifier: 07613153316961
• UDI-Public: 07613153316961
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K032898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 18471136S
• Device Lot Number: K0B9CE3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 11/23/2022; 03/18/2024
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 12/21/2022; 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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: 70 YR
• Patient Sex: Male