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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - ELASTIC NAILS: TITANIUM; PIN, FIXATION, SMOOTH

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SYNTHES GMBH UNK - ELASTIC NAILS: TITANIUM; PIN, FIXATION, SMOOTH Back to Search Results
Device Problem Migration (4003)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
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).Literature article is being submitted with this medwatch.This report involves one unk - elastic nails: titanium.This is report 1 of 4 for (b)(4).
 
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 elastic nails: titanium/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.
 
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Brand Name
UNK - ELASTIC NAILS: TITANIUM
Type of Device
PIN, FIXATION, SMOOTH
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 Key15454795
MDR Text Key300225981
Report Number8030965-2022-07107
Device Sequence Number1
Product Code HTY
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
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? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/30/2022
Initial Date FDA Received09/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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