MAUDE Adverse Event Report: SYNTHES GMBH RFNA/ 10MM/ 320MM/ STANDARD BEND/ STER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.233.032S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
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.D2b: additional product code: hwc.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.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
Study id: (b)(6).Subject id: (b)(6).It was reported that post-op wound infection occurred.This report is for one (1) rfna/ 10mm/ 320mm/ standard bend/ ster.This is report 1 of 7 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.Manufacturing location: monument manufacturing date: 09-mar-2023 expiration date: 31-jan-2028 part number: 04.233.032s, rfn/10mm/320mm std bend/pe inlay/sterile lot number: 6728p82 (sterile) lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection plan, 04.233.024s-12-btq897283 / 3.Met all inspection acceptance criteria.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Note: lmd revision was not identified on the packaging bom however, lmd document included in the dhr was rev d.Packaging label log (pll) was reviewed and determined to be conforming.Scn 24997 supplied by jabil (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging 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 ¿adverse event: post-op wound infection¿ 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/ 10MM/ 320MM/ 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: 19014936
• Report Number: 8030965-2024-04304
• Device Sequence Number: 20828560
• Product Code: HSB
• UDI-Device Identifier: 10886982289124
• UDI-Public: (01)10886982289124
• Combination Product (Y/N): N
• 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: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 04.233.032S
• Device Lot Number: 4848P78
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• 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: RFNA/ 10MM/ 320MM/ STANDARD BEND/ STER; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown