MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON Ø9X380 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1845-0938S
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/02/2022
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 the nail folded at the 4-month post-operative control resulting in a revision surgery.
Event or Problem Description
It was reported that the nail folded at the 4-month post-operative control resulting in a revision surgery.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received nail was found to be bent from the shaft region around middle.No major marks or signs were observed around the bend region indicating that no external force was applied to bend it prior to insertion.Upon reviewing the ap & ml view w.R.T.The drawing, the abnormal bend was confirmed.Dimensional inspection indicates that the device is within the specifications.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.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.The above investigation reveals two aspects of this case.Manufacturing & design wise, there was no anomaly found.As per the manufacturing documents, 100 of the devices from the lot were inspected for all the critical dimensions.No deviation from the specifications was noticed.From the use aspect, a bend in the nail as significant as in this case, can be easily identified during insertion.Also, bending initially can be observed through follow-up x-rays.With such a bend, insertion of the nail inside the im canal would be evidently very difficult.It can be said that due to some remarkable circumstances the nail bent post-operatively, the exact reason of which cannot be determined as more details like patient details, x-rays etc are needed for a proper evaluation and finding the root cause.The instructions for use clearly suggests the user that: "conditions attributable to non-union, osteoporosis, osteomalicia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.¿ if any additional information is provided, the investigation will be reassessed.

• Brand Name: RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON Ø9X380 MM X 125°
• 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: 16513418
• Report Number: 0009610622-2023-00078
• Device Sequence Number: 6239787
• Product Code: HSB
• UDI-Device Identifier: 04546540412423
• UDI-Public: 04546540412423
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K102992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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 Expiration Date: 08/31/2024
• Device Model Number: 1845-0938S
• Device Catalogue Number: 18450938S
• Device Lot Number: K098B04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2019
• 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: 28 YR
• Patient Sex: Female
• Patient Weight: 58 KG