MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: VA-LCP TARSAL/NAVICULAR/CUBOID; PLATE,FIXATION,BONE

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

Patient Problems Arthritis (1723); Unspecified Infection (1930); Pain (1994); Deformity/ Disfigurement (2360); Physical Asymmetry (4573)

Event Type  Injury  

Event Description

Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: wang m., et al (2020) comparison of the mini-locking plate and external fixation in the treatment of dice comminuted fracture, china tissue engineering research, volume 24 (6): pages 843-849 (china).This retrospective analysis of the data of patients with dice comminuted fractures treated with open reduction and miniature locking plates and external fixators compared their clinical and imaging effects.From january 2013 to march 2018, data of 43 patients with dice comminuted fractures treated with open reduction and miniature locking plates and external fixators were analyzed.These patients were divided into two groups according to different treatment methods, that is, the miniature locking plate group (open reduction and internal fixation with miniature locking plate plus support therapy) and the external fixation group (external fixation plus support therapy).Mini-locking plate group of 23 cases, 13 males and 10 females; aged 21-65 years, (48.4 ±12.1) years on average.There were 20 patients in the external fixation group, 12 males and 8 females, aged 17-68 years, with a mean one of (44.5 ± 13.8) years.The material micro-locking bone plate was provided by johnson & johnson synthes.A miniature external fixation system is provided by orthofix company.All patients were followed up by an independent orthopedic surgeon at 3 months, 6 months, 1 year, and 3 months after surgery.The average follow-up period was 4.1 years.Reported complications: lateral arch collapse and significant abduction deformity of the forefoot were found at radiographic follow-up in both groups, arthritis of the calcaneocuboid joint with slight gait changes, was found in one 65-year-old patient in the miniature locking plate group at 1.5 years after surgery.Which could be relieved by local physiotherapy and non-steroid anti-inflammatory drug treatment.There was a significant difference in the loss of dice bone length between the two groups (p < 0.05).In the miniature locking plate group, 4 patients had persistent lateral foot pain after walking, which was relieved after local physiotherapy and oral administration of non-steroid drugs, 1 case of superficial infection, which healed after wound dressing change (the article does not identify which specific depuy synthes product (2.4/2.7mm ti locking cuboid plate-left or 2.4/2.7mm ti locking cuboid plate-right) is associated with the adverse event(s).) this report is for an unk - plates: va-lcp tarsal/navicular/cuboid a copy of the literature article is being submitted with this medwatch.This is report 1 of 2 for (b)(4).

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.Additional narrative: this report is for an unk - plates: va-lcp tarsal/navicular/cuboid/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: UNK - PLATES: VA-LCP TARSAL/NAVICULAR/CUBOID
• 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: 15520494
• MDR Text Key: 300996423
• Report Number: 8030965-2022-07640
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/30/2022
• 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: 09/13/2022
• 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