MAUDE Adverse Event Report: SYNTHES GMBH RFNA/ 11MM/ 420MM/ STANDARD BEND/ STER; SCREW, FIXATION, BONE

Catalog Number	04.233.142S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on an unknown date, that they had a patient come in with a hypertrophic non-union with a retrograde femoral nail advanced put in about 6 months ago.The construct included two a to p screws proximally and two lateral to medial screws distally.The two screws distally were in fact broken at the nail.The lateral fragments were removed using the t25xl screw driver.The medial pieces were pushed through the medial aspect of the femur.No pieces were left in the patient and the procedure was completed once the nail and screws were removed.The nail and screws are not available for return.The procedure was completed successfully with a surgical delay of 15 minutes.There were no patient outcomes reported.This report is for one (1) rfna/ 11mm/ 420mm/ standard bend/ ster.This is report 1 of 3 for complaint (b)(4).
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional product code: hsb.D9: complainant part is not expected to be returned for manufacturer review/investigation.H4, h6 manufacturing location: monument, manufacturing date: 31-mar-2022, expiration date: unknown, part number: 04.233.142s, rfn/11mm/420mm 5 degree bend/pe inlay/sterile, lot number: 640p161 (sterile).Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final, ns497993 rev d met all inspection acceptance criteria.Inspection sheet, rfn assembly inspection, ns529720 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 67961 was recorded on the production order traveler.The scn was reviewed and met specified dose ranges however, there was no linkage to specific lot numbers within the document.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 due to two distal screws broken at the nail and 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.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.

• Brand Name: RFNA/ 11MM/ 420MM/ STANDARD BEND/ STER
• Common Device Name: SCREW, FIXATION, BONE
• 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: 17930701
• Report Number: 8030965-2023-12933
• Device Sequence Number: 6472334
• Product Code: HWC
• UDI-Device Identifier: 10886982290694
• UDI-Public: (01)10886982290694
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• 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 Catalogue Number: 04.233.142S
• Device Lot Number: 640P161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown