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U.S. Department of Health and Human Services


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Catalog Number 391.962
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Device used for treatment, not diagnosis. Additional narrative: event date: unknown. Device is an instrument and is not implanted/explanted. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. Device history records review was conducted. The report indicates that the: part # 391. 962, lot #t113518, manufacturing date: 04-feb-2015. 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 03-feb-2015. No ncrs were generated during production. No service history review can be performed as part number 391. 962 with lot number(s) t113518 is a lot/batch controlled item. The manufacture date of this item is unknown. The source of the manufacture date is the release to warehouse date. The service history review is unconfirmed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The service and repair department documented that it was reported that a synthes bending/cutting pliers was discovered to be missing a piece. The issue was not discovered during a procedure and no patient or procedure were identified. There is a slot on the bending/cutting pliers that holds the plate and within the slot there are two small charcoal colored blocks that cut the plate. One of the small blocks is missing from the actual cutting portion of the pliers. It does not appear that the block is broken. Sales consultant noted the missing piece during inspection of the set at the hospital. There were no reports of patient involvement. This complaint involves one device. This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A service and repair evaluation was performed. The customer reported the device was missing a piece. The repair technician reported the carbide insert was missing. Missing 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. A product development investigation was performed. This complaint is confirmed. The carbide insert component is missing from the returned bending/cutting pliers. Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already missing the carbide insert. No new malfunctions were identified as a result of the investigation. The returned bending/cutting pliers are a reusable instrument available for use in several systems to cut or bend plates in order to better fit/contour to patient anatomy. A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation. Relevant drawing was reviewed during this investigation. No product design issues or discrepancies were observed. Unable to determine a root cause. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. 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 Key6441250
MDR Text Key71403860
Report Number9680938-2017-10052
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/07/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/28/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Catalogue Number391.962
Device LOT NumberT113518
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 Received04/20/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/04/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown