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U.S. Department of Health and Human Services


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Catalog Number 391.88
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. There was no reported patient involvement associated with the complained event. Device is an instrument and is not implanted/explanted. (b)(6). The subject device has been received and is currently undergoing investigation. A service and repair history record review has been requested. 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 (b)(6) reported the following event: it was reported that the 180 mm locking pliers have a broken support. It is unknown when the instrument was broken. There was no report or patient or surgical involvement. This report is 1 of 1 for com-(b)(4).
Manufacturer Narrative
Service history review was attempted. No service history review can be performed as part number 391. 88 with lot number(s) t924964/6007300 is a lot/batch controlled item. The manufacture date of this item is 16-oct-2008. The source of the manufacture date is the release to warehouse date. The service history review is unconfirmed. Device history records review was completed for part# 391. 88, lot# t924964. Manufacturing location: (b)(4), manufacturing date: sep 11, 2008. No non conformance reports were generated during production. Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint. A review of inspection records and certifications, confirm that the components and final product met inspection records. All (b)(4) parts of the lot were checked 100% for important features and for function at the final inspection on 09-sep-2008. Service and repair evaluation was completed. The customer reported the locking pliers had a broken support. The repair technician reported the teeth on the jaw were worn. Worn out parts is the reason for repair. The item is not repairable per the inspection sheet. The cause of the issue is unknown. The item will be forwarded to customer quality. The evaluation was confirmed. Product development investigation was completed. A visual inspection, dhr review, and drawing review were performed as part of this investigation. The device was returned and reported to have a broken support by the customer and have worn out teeth by service and repair. The device is not broken and no fracture surfaces are visible; this condition is unconfirmed. Assembly and disassembly instructions can be found in the epoca revision instrument set technique guide. The teeth along the jaws of the device are somewhat worn consistent with eight years of use. This condition is confirmed. It is likely that over eight years of consistent use has led to this complaint condition. The device was manufactured in 9/2008 and is over eight years old. The balance of the returned device is in otherwise fairly worn condition with markings and some areas of discoloration across its surface. Relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended. The condition of the returned device does agree with the complaint description. Whether the complaint condition for this device can be replicated is not applicable for this condition. 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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Manufacturer (Section D)
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer (Section G)
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
MDR Report Key6452488
MDR Text Key71481642
Report Number9680938-2017-10062
Device Sequence Number1
Product Code HTC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number391.88
Device Lot NumberT924964
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/11/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown