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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH K-WIRE 1 W/DOUB TIP L150 TAV; NAIL, FIXATION, BONE

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SYNTHES GMBH K-WIRE 1 W/DOUB TIP L150 TAV; NAIL, FIXATION, BONE Back to Search Results
Catalog Number 492.5
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Fluid Discharge (2686)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Event occurred on an unknown date in 2020.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 history review: part: 492.500, lot: 36p9279, manufacturing site: (b)(4), release to warehouse date: feb 10, 2020.A manufacturing record evaluation was performed for the finished device lot number 36p9279, and no non-conformances were identified.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: it was reported that on (b)(6) 2020 the patient suffered from erythema, inflammation and wound secretion after using the product in the surgery of debridement and exploration of left little finger, reduction and internal fixation of phalanx fracture, repair of blood vessel, nerve and tendon of little finger on (b)(6) 2020.It was considered that the patient had an allergy to kirschner wire and the wire was removed on (b)(6) 2020.The patient condition is reported to be better.This case is from a health authority.This report is for one (1) k-wire 1 w/doub tip l150 tav.This is report 1 of 1 for (b)(4).
 
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Brand Name
K-WIRE 1 W/DOUB TIP L150 TAV
Type of Device
NAIL, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
WERK BALSTHAL (CH)
dornacherstrasse 20
balsthal 4710
SZ   4710
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key10937520
MDR Text Key219347626
Report Number8030965-2020-09340
Device Sequence Number1
Product Code JDS
UDI-Device Identifier07611819066175
UDI-Public(01)07611819066175
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/06/2020
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
Device Catalogue Number492.5
Device Lot Number36P9279
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/06/2020
Initial Date FDA Received12/03/2020
Supplement Dates Manufacturer Received01/11/2021
Supplement Dates FDA Received01/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2020
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age49 YR
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