MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM LCP METAPHYSEAL PLATE 6 HOLES; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO

Catalog Number	223.406
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
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.B3: unknown event date.E1: initial reporter is j&j company representative.Without a lot number the device history records review could not be completed.Product was not returned.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
In collaboration with depuy synthes together with (b)(6) hospital a retrospective data collection was performed on patients who received locking compression plates.Dates are not included in the data due to privacy restrictions.Patient #10: 51-year-old male was implanted with lcp metaphyseal plates 3.5 (223.406) in ankle with dps screws (unknown quantity) with no adjunctive fixation device.Post-operative complication: infection experienced 12 weeks post-op related to both synthes device and procedure.Treatment: surgical treatment for i&d and hardware removal of plate and screws performed 12 weeks post-op.Outcome: recovered/resolved.This report is for one 3.5mm lcp metaphyseal plate 6 holes for (b)(4).

• Brand Name: 3.5MM LCP METAPHYSEAL PLATE 6 HOLES
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19315957
• Report Number: 8030965-2024-06258
• Device Sequence Number: 3088475
• Product Code: LXT
• UDI-Device Identifier: 10886982157584
• UDI-Public: (01)10886982157584
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033805
• 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

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: 223.406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 3.5MM LCP METAPHYSEAL PLATE 6 HOLES; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male