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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES HAGENDORF INSERTN HANDLE F/3.5MM LOW BNDMEDIAL DISTAL TIB PLATE/RIGHT GAUGE,DEPTH

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SYNTHES HAGENDORF INSERTN HANDLE F/3.5MM LOW BNDMEDIAL DISTAL TIB PLATE/RIGHT GAUGE,DEPTH Back to Search Results
Catalog Number 03.113.025
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
A service and repair evaluation was performed on subject device. The customer reported the insertion screw was missing. The repair technician reported the screw was missing. Missing parts is the reason for repair. The cause of the issue is unknown. The following parts were replaced: m3. 5 screw. The item was repaired per the inspection sheet, passed synthes final inspection on 1-jun-2017 and will be returned to the customer upon completion of the service and repair process. The evaluation was confirmed. 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.
 
Manufacturer Narrative
There was no known reported patient involvement associated with the complained event. Unknown when device malfunctioned. Device is an instrument and is not implanted/explanted. A device history record (dhr) review was performed for part # 03. 113. 025, lot # 3665631: manufacturing site:(b)(4), manufacturing date: 28. Jan. 2011: no non conformance reports (ncrs) were generated during production. Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Service history review was performed for part # 03. 113. 025, lot # 3665631: no service history review can be performed as part number 03. 113. 025 with lot number(s) 3665631 is a lot/batch controlled item. The manufacture date of this item is 1-feb-2011. The source of the manufacture date is the release to warehouse date. The service history review is unconfirmed. The device has been received and the product evaluation is in progress. No conclusion can be drawn. 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
It was reported that an insertion screw for an insertion handle is missing. No patient involvement reported. This report is for one (1) insertion handle. This is report 1 of 1 for complaint com-(b)(4).
 
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Brand NameINSERTN HANDLE F/3.5MM LOW BNDMEDIAL DISTAL TIB PLATE/RIGHT
Type of DeviceGAUGE,DEPTH
Manufacturer (Section D)
SYNTHES HAGENDORF
im bifang 6
hagendorf CH461 4
SZ CH4614
Manufacturer (Section G)
SYNTHES HAGENDORF
im bifang 6
hagendorf CH461 4
SZ CH4614
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6619838
MDR Text Key160449356
Report Number3003875359-2017-10274
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.113.025
Device Lot Number3665631
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/28/2011
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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