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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH COMPRESSION DRILL GUIDE F/3.5 MM LCP PERCUTANEOUS INSTR SYS GAUGE,DEPTH

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SYNTHES GMBH COMPRESSION DRILL GUIDE F/3.5 MM LCP PERCUTANEOUS INSTR SYS GAUGE,DEPTH Back to Search Results
Catalog Number 03.113.013
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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 patient underwent the open reduction internal fixation surgery for the proximal humeral fracture. Before the surgery, when the hospital checked the devices, a drill bit couldnt be inserted into the drill sleeve. No further information is available. This report is for one (1) compression drill guide f/3. 5 mm lcp percutaneous instr sys. This is report 1 of 2 for complaint (b)(4).
 
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Brand NameCOMPRESSION DRILL GUIDE F/3.5 MM LCP PERCUTANEOUS INSTR SYS
Type of DeviceGAUGE,DEPTH
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
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key11359252
MDR Text Key239431705
Report Number8030965-2021-01220
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
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
Report Date 01/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.113.013
Device Lot Number9901067
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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