MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: DYNAMIC COMPRESSION PLATE/SCREWS; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

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

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: quan-zhou w., shu-ming h., qi-xun c., (2014) titanium elastic nail versus plate-screw fixation for the treatment of upper segment fractures of femoral shaft in children, china j orthop trauma volume 27, no.10 , pages 1-6 (china).This study aims to compare complications and outcome of titanium elastic nail versus plate-screw fixation for the treatment of upper segment fractures of femoral shaft in children.From january 2006 to august 2012,a total of 32 children ages 3 - 12 years with middle and upper segment femoral fractures were treated with titanium elastic nail (ten) and plate-screw fixation (pf).These patients were randomly selected for treatment with titanium elastic nail and plate-screw fixation.In the titanium elastic nail group , where a titanium elastic nail (ten) was used, there were 19 patients, including 11 males and 8 females; the ages were 3 -11 years old, with the average age being (6.9 ± 2.2) years old.In the plate-screw fixation group, where a plate-screw (dcp/lcp) plate were used, there were 13 patients, including 9 males and 4 females; the ages were 5 - 12 years old, with the average age being (7.5 ± 2.1) years old.The follow-up time of the titanium elastic nail group was 15 - 48 months, with an average of 25.3 months; the follow-up time of the plate-screw fixation group was 13 - 36 months, with an average of 21.6 months.The following complications were reported: titanium elastic nail group: 1 superficial infection of incision occurred, which was cured after dressing change.2 nail tail irritation, which was cured when the internal fixation was removed after fracture healing.2 pain at the site of nail tail implantation, which affected knee joint flexion and extension, and was obvious in 1 patient, the symptoms disappeared after removing the intramedullary nail.3 limb length inequality occurred, at the last follow-up.1 angulation deformity.1 rotational deformity.1 poor result of hip joint function result.Plate-screw fixation group: 2 limb length inequality.This report is for an unknown synthes (dcp/lcp) plate and unknown synthes titanium elastic nail (ten).This report is for (1) unk - constructs: dynamic compression plate/screws.This report is 2 of 3 (b)(4).

• Brand Name: UNK - CONSTRUCTS: DYNAMIC COMPRESSION PLATE/SCREWS
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 11787085
• MDR Text Key: 264524696
• Report Number: 8030965-2021-03659
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• 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: 04/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention