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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG V MUELLER LOVE-GRUENWALD FORCEPS MANUAL RONGEUR

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S.U.A. MARTIN GMBH &CO.KG V MUELLER LOVE-GRUENWALD FORCEPS MANUAL RONGEUR Back to Search Results
Catalog Number 023050 / NL6092
Device Problems Fracture (1260); Dent in Material (2526)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/13/2019
Event Type  malfunction  
Manufacturer Narrative
During inspection of the returned device notches were observed on the cutting edge of the tip. This type of damage is usually caused by misuse, such as grasping or cutting metallic objects, leading to overstress and breakage of the instrument. Review of manufacturing documents showed that the device conformed to specifications at the time of release. Hardness of the returned device was tested and found to conform to specifications. The device was manufactured and sold in 2006 and may have been in use for up to 13 years, well above its three-year lifetime.
 
Event Description
During revision of total knee replacement, the upper portion of the jaw of a pituitary forceps was seen breaking and falling into the femoral canal. It was immediately retrieved and the procedure was completed as planned. No patient issues were observed.
 
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Brand NameV MUELLER LOVE-GRUENWALD FORCEPS
Type of DeviceMANUAL RONGEUR
Manufacturer (Section D)
S.U.A. MARTIN GMBH &CO.KG
uhlandstrasse 17
rietheim-weilheim, 78604
GM 78604
Manufacturer (Section G)
S.U.A. MARTIN GMBH &CO.KG
uhlandstrasse 17
rietheim-weilheim, 78604
GM 78604
Manufacturer Contact
markus pauli
uhlandstrasse 17
rietheim-weilheim, 78604
GM   78604
MDR Report Key8811295
MDR Text Key151724067
Report Number8010386-2019-00002
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 07/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number023050 / NL6092
Device Lot NumberXMEE12
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/22/2019 Patient Sequence Number: 1
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