MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Nerve Damage (1979); Pain (1994)

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown constructs: plate/screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 china as follows: this report is being filed after the review of the following journal article: wu, y.Et al (2020), comparison of clinical efficacy of nice knot assisted intramedullary nailing and plate fixation in the treatment of adult midshaft clavicle fracture, chinese journal of hand surgery, vol.36 (6), pages 435-439 (china).The aim of this study is to compare the clinical efficacy of nice knot assisted intramedullary nailing and traditional incision plate fixation in the treatment of midshaft clavicle adult fracture.Between march 2016 to january 2018, a total of 82 patients were included in the study.The patients were divided according to different treatment methods: 26 cases (17 male and 9 female; average age of 41 years [18 to 60 years]) in the intramedullary nail group with robinson fracture classification of type 2a in 6 cases, type 2b1 in 16 cases and type 2b2 in 4 cases; 56 cases (42 male and 14 female; average age of 44 years [20 to 65 years]) in the traditional incision plate group with robinson fracture classification of type 2a in 10 cases, type2b1 in 26 cases and type 2b2 in 20 cases.Surgery was performed using elastic nail (synthes) in the intramedullary nail group and an anatomical plate (synthes) in the traditional incision plate group.The intramedullary nail group and the traditional incision plate group were followed up for (19.6 ± 6.1) months and (21.8 ± 7.6) months respectively.The following complications were reported as follows: intramedullary nail group: 1 patient had elastic nail bending 3 months after surgery due to early postoperative active movement, and no fracture healing was observed after immobilization treatment.Nine months after surgery, the patient was re-hospitalized due to hypertrophic nonunion to remove the elastic nail, replace the plate internal fixation and at the same time, and the fracture healed well during follow-up at 4 months after surgery.1 patient had intramedullary nail withdrawal 36 d after operation, the nail tail protruded locally, irritating the skin, which was improved after cutting off the nail tail under outpatient local anesthesia, the fracture healed well at a later stage, without skin irritation, and the internal fixation was removed 11 months after operation.Plate group: 3 patients had local skin hypoesthesia of clavicle and symptoms of clavicular epithelial nerve injury.1 patient had refracture 5 days after the second removal of internal fixation due to upper limb exertion.1 patient had postoperative incision site pain, which was relieved after removal of internal fixation.This report is for an unknown synthes elastic nails and unknown synthes plate/screws constructs.This report involves one unk - constructs: plate/screws.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• 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: 15488987
• MDR Text Key: 300638511
• Report Number: 8030965-2022-07373
• Device Sequence Number: 1
• Product Code: HRS
• 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

• Date FDA Received: 09/26/2022
• 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: 09/06/2022
• 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