MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP; PLATE, FIXATION, BONE

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

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369)

Event Date 04/16/2021

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, d2, d3, d4, g4 ¿ 510k: this report is for an unknown construct: lcp/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.Product was not returned.Based on the information available, it has been determined that no corrective and 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

This report is being filed after the review of the following journal article: malhorta, r.Et al (2023), posterolateral plating of distal tibia fractures: extending the use of a familiar approach, indian journal of orthopaedics vol.55 (suppl 2), pages 426¿435 (singapore).This study analyzed a series of patients that have undergone open reduction and plating of distal tibial fractures using a posterolateral approach.Between 2015 to 2018 a total of 13 patients (6 male and 7 female) were included in the study.These patients underwent posterolateral plating surgery for a distal tibia fracture using either a metaphyseal locking compression plate (lcp) or proximal posteromedial tibia lcp.All patients were followed up until union or complication or re-operation was done except for 1 patient that never returned for follow-up after discharge.Therefore, only a total of 12 patients could be analyzed for long term outcomes.The following complications were reported as follows: a 56-year-old male had implant failure with plate backing out leading to nonunion; required for re-operation.1 patient suffer a delayed union from an infection around the medial implant; implant was removed at 6 months from definitive surgery.A copy of the literature article is being submitted with this medwatch.This report is for an unk - construct: lcp.This is report 3 of 3 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: LCP
• 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: 18873924
• MDR Text Key: 337307438
• Report Number: 8030965-2024-03448
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 03/11/2024
• 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: 02/19/2024
• 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