MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 3.5 MM LCP CLAVICLE PLATES; PLATE, FIXATION, BONE

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

Patient Problem Skin Erosion (2075)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: storti t.M., et al (2021) clinical evaluation of the treatment of clavicle fractures: intramedullary nail × plate, acta ortop bras.[online].Volume 29(1), pages 34-38 (brazil).This retrospective cohort study aims to compare the clinical and radiographic results of patients subjected to surgical fixation treatment with intramedullary plate or nail of fractures diverted from the body of the clavicle, since they are the two most used techniques.From january 2011 to august 2017, 95 patients operated for surgical treatment with fractures diverted from the clavicle midshaft fixed with plate and screws or flexible titanium nail were evaluated.Of these, 65 were included.Of the 65 volunteers, 36 (33 males and 3 females) with mean age of 37.5 (18 ¿ 69 years ) were subjected to fixation of the clavicle with plate and 29 (23 males and 6 females) with mean age of 37.8 (18 ¿ 75 years ) with intramedullary nail.In the group of patients subjected to fixation of fractures with plate and screws, synthes® precast blocked lcp plates of 3.5 mm stainless steel for clavicle were used.The intramedullary nail was removed at the end of treatment, but the plate was removed only in cases in which they caused discomfort.Thus, the average follow-up period of patients treated with plate was longer than patients treated with intramedullary nail (3 years and 4 months and 1 year and 7 months, respectively).The following complications were reported: -most patients in both groups evolved without pain; however, when pain remains present, the tendency is to be in patients fixed with plate and screws.Immediate postoperative pain : mild: (n=16) , moderate (n=7) and intense (n=7).Current pain: mild (n=6) 1 consolidation delay in a single case 3 weeks after surgery, the fracture was not yet consolidated, and the plate was replaced by the nail, with subsequent consolidation.1 surgical site infection.A median shortening of 0.9 mm (interval -3.5 - 14) was observed in the plate group.2 prosthesis loosening (plate loosening).1 break of the synthesis material (plate breakage).4 skin erosion with synthesis material exposure (plate exposure).All patients were treated with plate removal and necrotic tissue debridement.This report is for an unknown synthes precast blocked lcp plates of 3.5 mm stainless steel.This report is for one (1) unk - plates: 3.5 mm lcp.This is report 4 of 4 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - plates: 3.5 mm lcp/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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The 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.

• Brand Name: UNK - PLATES: 3.5 MM LCP CLAVICLE PLATES
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12667051
• MDR Text Key: 282346716
• Report Number: 8030965-2021-08829
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

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: 09/22/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 12/20/2021
• 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