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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH CONNECSCR CANN F/MULTILOC HUM NAIL SYST ORTHOPAEDIC INSTRUMENT SURGICAL CONNECTOR

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SYNTHES GMBH CONNECSCR CANN F/MULTILOC HUM NAIL SYST ORTHOPAEDIC INSTRUMENT SURGICAL CONNECTOR Back to Search Results
Catalog Number 03.019.007
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2022
Event Type  malfunction  
Event Description
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that preoperatively to an unknown surgery on (b)(6) 2022, it was observed that the hollow part on the connecting screw device was stained even it was wiped with a cotton swab. It was further reported that the device had dirt came out even after carefully checking. No additional information was provided. This report is for one (1) connecscr cann f/multiloc hum nail syst. This complain involves one(1) device.
 
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j sales representative. 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.
 
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Brand NameCONNECSCR CANN F/MULTILOC HUM NAIL SYST
Type of DeviceORTHOPAEDIC INSTRUMENT SURGICAL CONNECTOR
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14115395
MDR Text Key289449170
Report Number8030965-2022-02441
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,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 Received04/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.019.007
Device Lot Number8404292
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2013
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: 04/14/2022 Patient Sequence Number: 1
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