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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES TUTTLINGEN AWL 12MM

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SYNTHES TUTTLINGEN AWL 12MM Back to Search Results
Catalog Number 03.820.100
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Device is an instrument and is not implanted/explanted. Manufacturing date: september 18, 2007. 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 parts of the lot were checked 100% for features and for function at the final inspection. No non-conformance reports were generated during production. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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 the tip was found broken off of the awl during inspection activities of the evaluation set. There was no patient involvement. This is report 1 of 1 for (b)(4).

 
Manufacturer Narrative

Device was used for treatment, not diagnosis. One (1) 12mm awl (part 03. 820. 100, lot a7qa38, mfg 18-sep-2007) was returned with a complaint stating that the tip of the awl was discovered broken during inspection of the evaluation set. The complaint was able to be confirmed at customer quality as a portion of the distal tip had sheared off. A visual inspection and drawing review were performed as part of this investigation. Replication of the complaint is not applicable as the device was received broken. The broken fragment was not returned. Although the definitive root cause could not be determined, the pattern of the deformation insists that the damage likely occurred during a clockwise twisting motion during use. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. The 12mm awl (also referred to as the center punch) is an instrument regularly used in the prodisc-c modular intervertebral disc prosthesis systems (per relevant technique guide). The awl is used to perforate the anterior cortex of the superior and inferior vertebra in the lateral midline and vertical center. Product drawing was reviewed during the investigation. The design, materials and finishing processes were found to be appropriate for the intended use of these devices. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. 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 NameAWL 12MM
Type of DeviceAWL
Manufacturer (Section D)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5986593
MDR Text Key56546543
Report Number9680938-2016-10153
Device Sequence Number1
Product Code HWJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/12/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/29/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number03.820.100
Device LOT NumberA7QA38
OTHER Device ID Number(01)10705034731360(10)A7QA38
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/12/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/18/2007
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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