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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES HAGENDORF 12.0MM CANNULATED AWL

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SYNTHES HAGENDORF 12.0MM CANNULATED AWL Back to Search Results
Catalog Number 03.010.040
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/08/2016
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: patient information is unknown. Device is an instrument and is not implanted/explanted. (b)(6). Manufacturing site: (b)(4). Manufacturing date: december 22, 2010. No non-conformance reports were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the tip of the awl broke off during a tibia fracture procedure using etn. It was while using the entry 12mm cannulated awl that the tip broke off. They were able to remove the piece that broke off from inside the patient, with no known adverse effects. The instrument was not required again for this procedure so there was no delay to surgery time. No patient harm was reported. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Product investigation summary: upon visual inspection of the complaint device, it can be seen that on the distal end of the device there is a chip on the tip, which confirms the complaint description. A device history record (dhr) review was performed for the affected lot with no abnormalities or deviations detected. No non-conformance reports were marked in the dhr during production. A root cause could not be determined; however, it was most likely rough handling or the use of excessive force during surgeries over the device¿s 5 year lifespan that led to the complaint description. To prevent such problems, it is necessary for worn or damaged instruments to be replaced prior to usage. No product fault could be detected. No manufacturing related issues were identified and/or confirmed. Device 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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Brand Name12.0MM CANNULATED AWL
Type of DeviceAWL
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
terry callahan
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5672763
MDR Text Key45699482
Report Number3003875359-2016-10313
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PEXEMPT
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 05/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.010.040
Device Lot Number3653763
Other Device ID Number(01)07611819760813(10)3653763
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2010
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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