MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP; SCREW, FIXATION, BONE

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

Patient Problems Numbness (2415); Post Operative Wound Infection (2446)

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: lcp/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

Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: peng, l.Et al.(2018), comparison of elastic intramedullary nail and locking plate in the treatment of midshaft clavicle fracture, chinese journal of tissue engineering research, vol.22(11), pages 1671-1676 (china).The objective of this study is to compare the clinical results and complications of locking plate and elastic medullary needle in the treatment of midshaft clavicle fracture.From 2014 to june 2015, 85 patients with midshaft clavicle fractures received surgical treatment.These patients were divided into 2 groups according to different internal fixations, 62 patients (39 males and 23 females) in the locking plate group and 23 patients (14 males and 9 females) in the elastic medullary nailing group.Both devices were manufactured by johnson & johnson.The following complications were reported as follows: elastic intramedullary nailing group: medullary nail withdrawal and corresponding skin irritation symptoms (n=2).A 27-year-old female patient had nail withdrawal during the follow-up at 3 months after operation.Locking plate group: postoperative superficial incision infection (n=2).Postoperative peri-incision skin hypoesthesia (n=8).Postoperative internal implant protrusion discomfort (n=7).This report involves one unk - constructs: lcp.This is report 4 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: LCP
• Type of Device: SCREW, 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: 15454946
• MDR Text Key: 300229891
• Report Number: 8030965-2022-07110
• 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: 09/20/2022
• 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: 08/30/2022
• 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