MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: EXPERT TIBIAL NAIL; NAIL, FIXATION, BONE

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

Patient Problems Inflammation (1932); Pain (1994)

Event Date 01/01/2020

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.Additional narrative: 510k: this report is for an unknown construct: expert tibial nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: 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 liu, m.(2020) primary exploration of diagnosis and treatments of distal tibial osteoepiphys is fatigue fractures in female gymnasts, investigación clínica, vol.61 (01) pages 339-346 (china).The aim of this study is to explore the diagnosis and treatments of female gymnasts with distal tibial fractures treated in the orthopedics department of the xx hospital were selected as research objects and were divided into the expert tibia nail (etn) group and the locking compression plate (lcp) group.Between march 2016 to march 2018, a total of 87 female gymnasts with an age range of 18-48 years were diagnosed with distal tibial fractures treated in the orthopedics department of the xx hospital were selected as research objects and were divided into the expert tibia nail (etn) group and the locking compression plate (lcp) group.Patients in both groups were treated with corresponding surgical treatments, and each indicator was recorded in the preoperative, perioperative, and postoperative periods to observe and compare the therapeutic effects through statistical analysis, which provided an experimental basis for the treatments of distal tibial fractures.The following complications were reported as follows: expert tibial nail group: 4 patients had a fine therapeutic effect according to mazur ankle joint score (as defined with slight swellings and pains in the ankle joints of patients, normal gaits, and 3/4 of the normal activities that could be performed by healthy people).3 patients had fair therapeutic effect according to mazur ankle joint score (as defined with pains during exercising l/2 of the normal activities that could be performed by healthy people, and the need for non­ steroidal anti-inflammatory drugs frequently.1 patient had poor therapeutic effect according to mazur ankle joint score (as defined with less than 65 points, with pains during walking or sitting, 1/2 of the normal activities that could be performed by healthy people, claudication, and swellings in ankle joints).Locking compression plate group: 5 patients had a fine therapeutic effect according to mazur ankle joint score (as defined with slight swellings and pains in the ankle joints of patients, normal gaits, and 3/4 of the normal activities that could be performed by healthy people).4 patients had fair therapeutic effect according to mazur ankle joint score (as defined with pains during exercising l/2 of the normal activities that could be performed by healthy people, and the need for non­ steroidal anti-inflammatory drugs frequently).2 patients had poor therapeutic effect according to mazur ankle joint score (as defined with less than 65 points, with pains during walking or sitting, 1/2 of the normal activities that could be performed by healthy people, claudication, and swellings in ankle joints).This report is for an unk - construct: expert tibial nail.A copy of the literature article is being submitted with this medwatch.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: EXPERT TIBIAL NAIL
• Type of Device: NAIL, 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: 16257000
• MDR Text Key: 308299388
• Report Number: 8030965-2023-01085
• Device Sequence Number: 1
• Product Code: JDS
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

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: 01/09/2023
• Initial Date FDA Received: 01/27/2023
• 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