MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM/3.5MM LCP® METAPHYSEAL PLATE 9 HOLES; APPLIANCES,FIXATION,NAIL/BLD/ PL COMBO,MULTI COMP, METAL COM

Catalog Number	224.754
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	01/24/2024
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.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
Subject (b)(6).It was reported that a clinical adverse event was received for loss of fracture reduction treatment/impact: recommended follow-up with plastic surgery and infectious disease.Recommend continued use of telfa and silvadene dressings over the healing wounds.The patient will remain non-weightbearing of the left lower extremity.This report is for one (1) 4.5mm/3.5mm lcp® metaphyseal plate 9 holes.This is report 1 of 2 for complaint (b)(4).

• Brand Name: 4.5MM/3.5MM LCP® METAPHYSEAL PLATE 9 HOLES
• Common Device Name: APPLIANCES,FIXATION,NAIL/BLD/ PL COMBO,MULTI COMP, METAL COM
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 20066267
• Report Number: 8030965-2024-10362
• Device Sequence Number: 12885905
• Product Code: LXT
• UDI-Device Identifier: 10886982158680
• UDI-Public: (01)10886982158680
• 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: 224.754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/26/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown