MAUDE Adverse Event Report: SYNTHES GMBH RFNA/ 11MM/ 380MM/ STANDARD BEND/ STER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.233.138S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	05/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: monument, manufacturing date: 23-aug-2022, expiration date: unknown, part number: 04.233.138s, rfn/11mm/380mm 5 degree bend/pe inlay/sterile, lot number: 904p955 (sterile).One piece was scrapped in cell at gun drill, for after a tooling breakage.Production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, in-process / inspect dimensional / final rev d met all inspection acceptance criteria.Inspection sheet, rfn assembly inspection, rev b met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Note: scn was recorded on the production order traveler, however, it was unavailable for review.There was no pll included in this dhr.Therefore, the pll for this lot could not be reviewed and the expiration date could not be notated.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿removal and revision due to non-union¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device visual analysis of the photo revealed that the rfna/ 11mm/ 380mm/ standard bend/ ster had no signs of issue.The x-ray evidence shows four screws and nail implanted.The bone presents signs of non-union fracture at the distal section of the femur.With the available information and since the devices do not appear to have any defect or malfunction, a root cause cannot be established for the non-union condition of the bone fracture.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the rfna/ 11mm/ 380mm/ standard bend/ ster.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that patient had a removal of rfna and revision to replacement rfna/ va condy construct due to non-union.There was no surgical delay.This report is for one (1) rfna/ 11mm/ 380mm/ standard bend/ ster.This is report 1 of 5 for complaint: (b)(4).

• Brand Name: RFNA/ 11MM/ 380MM/ STANDARD BEND/ STER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17030862
• Report Number: 8030965-2023-06834
• Device Sequence Number: 17895599
• Product Code: HSB
• UDI-Device Identifier: 10886982290670
• UDI-Public: (01)10886982290670
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K201346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: Health Professional
• Device Model Number: 04.233.138S
• Device Catalogue Number: 04.233.138S
• Device Lot Number: 904P955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female