MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: VA-LCP X-PLATE FOREFOOT/MIDFOOT SYSTEM; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Necrosis (1971); Non-union Bone Fracture (2369); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

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.D1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown plates: va-lcp x-plate forefoot/midfoot system/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.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 Description

Device report from synthes reports an event in germany as follows: this report is being filed after the review of the following journal article: hans zwipp., stefan rammelt.,(2006), modified evans osteotomy for the operative treatment of acquired pes planovalgus, oper orthop traumatol, no.2 pages 182-197 (germany).This study aims to investigate restoration of the longitudinal arch of the foot and reorientation of the hindfoot for painful decompensating flat-foot (pes planovalgus) due to posterior tibial tendon dysfunction.Between june 1995 to march 2003, a total of 21 patients, 17 female and 4 male, ages; 42-72 years, average 54 years with stage ii painful pes planovalgus as described by johnson & strom underwent a modified evans osteotomy and were treated with h-small plates for cervical spine; small x-plates (synthes, paoli, pa, usa).Follow up period: 12-81 months, average 48 months.The following complications were reported as follows: wound edge necrosis with dehiscence of the wound margins in one of the 21 patients; healed after local revision.Non union in one of the 21 patients.Temporary irritation of the lateral dorsal cutaneous nerve in one case.This report is for an unknown synthes h-small x-plate/screws.This is report 1 of 1 for complaint (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - PLATES: VA-LCP X-PLATE FOREFOOT/MIDFOOT SYSTEM
• Type of Device: PLATE, FIXATION, BONE
• 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: 17807168
• MDR Text Key: 324129400
• Report Number: 8030965-2023-12058
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention