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

Device Problem Device Slipped (1584)

Patient Problems Malunion of Bone (4529); 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.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.

Event Description

Device report from synthes reports an event in india as follows: this report is being filed after the review of the following journal article: dr.Rushikesh lonikar, shailendra thaware., (2022)/clinical study of surgery with locking compression plate in clavicular fractures in adults, european journal of molecular & clinial medicine, volume 09, issue 04, 1026, 3665-3670 (india).This study aims to assess the functional outcome following the repair of displaced clavicular fractures with locking compression plates.The present study consists of 20 patients of type-2 middle third fracture type-2 b1 (displaced with simple or single butterfly fragment) occurred in 17 patients (85%) and type-2 b2 (displaced with comminuted or segmental) fracture occurred in 3 patients (15%).Majority of the patients were from age group of 19-29 years (40%).90% were male cases and 10% were female cases.They were treated surgically with locking plate & screws for middle third clavicle fracture.Follow-up on 10 days, 1 month, 2 months, 6 months.The following complications were reported as follows: 3 patients (15%) had hypertrophic skin scar.2 patients (10%) had plate prominence.2 patients (10%) had delayed union occurred.1 patient (5%) had plate loosening occurred which went for malunion.This report is for an unknown synthes clavicular locking compression plate.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 2 for (b)(4).

• 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: 16627278
• MDR Text Key: 312117690
• Report Number: 8030965-2023-03727
• 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
• 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?: Yes
• 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