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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BENDING/CUTTING PLIERS PLIERS, SURGICAL

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OBERDORF SYNTHES PRODUKTIONS GMBH BENDING/CUTTING PLIERS PLIERS, SURGICAL Back to Search Results
Catalog Number 391.962
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Type  Injury  
Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Initial reporter is a synthes employee. 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 (b)(6) reports an event as follows: it was reported that on an unknown date, the patient underwent a surgery. During the surgery, a bit of the pliers broke. The fragment might have remained in the body. No further information is available. This report is for a bending/cutting pliers. This is report 1 of 1 for (b)(4).

 
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Brand NameBENDING/CUTTING PLIERS
Type of DevicePLIERS, SURGICAL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS 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 Key8893545
MDR Text Key154419130
Report Number8030965-2019-67231
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 07/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number391.962
Device LOT NumberT155562
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/19/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/30/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/14/2019 Patient Sequence Number: 1
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