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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES PLATE,FIXATION,BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES PLATE,FIXATION,BONE Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/21/2020
Event Type  malfunction  
Manufacturer Narrative
This report is for an unk - plates: trauma/unknown lot. Part and lot numbers are unknown; udi number is unknown. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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 underwent the surgery for distal radius ulna fractures. During the surgery, the surgeon had a difficulty engaging the drill sleeve with a plate. As soon as he engaged it successfully, it come off. Such event happened repeatedly during the surgery. The procedure was completed successfully with any delay reported. The patient outcome was unknown. This complaint involves two (2) devices. This is report 2 of 2 for (b)(4).
 
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Brand NameUNK - PLATES
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester 19380
6103142063
MDR Report Key10110943
MDR Text Key193390857
Report Number8030965-2020-03865
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
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 05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/02/2020 Patient Sequence Number: 1
Treatment
LCP DRILL SLEEVE 2 W/SCAL F/DRILL BIT Ø1
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