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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH CUTTER F/ETN Ø12 L358 INSTRUMENT, CUTTING, ORTHOPAEDIC

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SYNTHES GMBH CUTTER F/ETN Ø12 L358 INSTRUMENT, CUTTING, ORTHOPAEDIC Back to Search Results
Catalog Number 03.010.511
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j employee. Device is not distributed in the united states, but is similar to device marketed in the usa. 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 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, the devices were found to be dirty prior to a procedure. No patient involvement. This report is for one (1) cutter f/etn ø12 l358. This is report 3 of 3 for complaint (b)(4).
 
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Brand NameCUTTER F/ETN Ø12 L358
Type of DeviceINSTRUMENT, CUTTING, ORTHOPAEDIC
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13367941
MDR Text Key290282312
Report Number8030965-2022-00574
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.010.511
Device Lot NumberT120964
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/07/2016
Is the Device Single Use? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/27/2022 Patient Sequence Number: 1
Treatment
COMBINED HAMMER 500G F/03.010.170; DRILL BIT Ø12 CANN L190 3FLUTE F/DHS/DCS
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