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

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

Patient Problem 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.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 construct: lcp clavicle plate/screws/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.

Event Description

This report is being filed after the review of the following journal article anand, a.Et al (2023) functional outcome of surgical management for clavicle fractures by osteosynthesis using plate and screws, european journal of molecular & clinical medicine, vol.10: pages 729-742 (india) the aim of this retrospective study is to assess the functional outcome of surgical management for clavicle fractures by osteosynthesis using plate and screws.A total of 30 patients, (7 female and 23 male).19 patients were in the age group 20 to 40 years, 8 patients were in the age group 41 to 60 years, and 3 patients were more than 60 years of age.19 patients underwent operative procedures with reconstruction using a locking compression plate (lcp) for the treatment of clavicle midshaft fractures.The following complications were reported as follows: n= 3 patients experienced delayed union n= 3 patients had skin scars n= 2 patients experienced plate prominence n= 1 patient experienced plate loosening n= 1 patient had a restriction of shoulder range of motion this report is for an unk - construct: lcp clavicle plate/screws.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: LCP CLAVICLE PLATE/SCREWS
• 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: 16628961
• MDR Text Key: 312147843
• Report Number: 8030965-2023-03752
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 04/25/2023
• Supplement Dates FDA Received: 05/10/2023
• 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): Other; Required Intervention