MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS: CALCANEAL; PLATE, FIXATION, BONE

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

Patient Problems Arthritis (1723); Non-union Bone Fracture (2369); Malunion of Bone (4529)

Event Type  Injury  

Event Description

Device report from synthes reports an event in saudi arabia as follows: this report is being filed after the review of the following journal article: alajmi, t.Et al.(2022), minimally invasive sinus tarsi approach for open reduction and internal fixation of calcaneal fractures: complications, risk factors, and outcome predictors, cureus, vol.14(1): e21791, pages 1-12 (saudi arabia) the current study aims to evaluate the less invasive sinus tarsi approach and to elaborate on the associated complications, risk factors, and outcome predictors.Between january 2019 and january 2020, 39 patients diagnosed with calcaneal fractures were treated with a minimally invasive calcaneus plate available from synthes 2.4/2.7 mm val plate.The age of included cases ranged between 16 and 62 years with a mean (34.46 + 12.332); 31 males in comparison to eight females were involved.The following complications were reported as follows: 5 patients required further revision surgery to subtalar arthrodesis within the following 6 to 9 months due to mal-/non-union and early arthritis.This report is for an unknown synthes calcaneus plate.A copy of the literature article is being submitted with this medwatch.This is report 1 of 1 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 unknown device/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 - CONSTRUCTS: PLATE/SCREWS: CALCANEAL
• 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: 15373522
• MDR Text Key: 299449113
• Report Number: 8030965-2022-06505
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 09/07/2022
• 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: 08/15/2022
• 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