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

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

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: wurm, m., et.Al., (2021), excellent clinical and radiological outcome following locking compression plate fixation of displaced medial clavicle fractures, bmc musculoskelet disorder, vol.22 (905) pages 1-7, (germany).The aim of this retrospective trial was to evaluate the clinical and radiological outcome using an anatomically precontoured locking plate originally designed for the lateral clavicle after a follow-up of at least one year.Between september 2012 and december 2019, a total of 15 patients (12 male, 3 female) with a mean age of 50.5 ± 24.4 years were operatively treated for a displaced medial clavicle fracture using an anatomically precontoured locking compression plate.Neither minor (wound-healing disorders etc.) nor major (non-union, re-fracture, revision etc.) complications were observed during follow-up examinations in our outpatient clinic for medial clavicle fractures.No re-fractures were observed until last follow up examination.Bone healing was found on conventional radiographs performed at the follow-up examinations in all patients after a mean of 6.4 ± 3.9 months.Mean follow up was 40.9 ± 26.2 months with a minimum follow up of 12 months (range 12.6 - 83.2 months).The following complications were reported as follows: overall 7 implant removals were performed due to soft tissue irritation and patients¿ request after a mean of 22.2 ± 8.0 months.A copy of the literature article is being submitted with this medwatch.This report involves one unk plates: lcp clavicle plate.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.This report is for an unknown plates: lcp clavicle plate /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: LCP CLAVICLE PLATE
• 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: 16626983
• MDR Text Key: 312116654
• Report Number: 8030965-2023-03722
• 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: 03/28/2023
• 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: 03/09/2023
• 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