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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT AWL

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SYNTHES MONUMENT AWL Back to Search Results
Catalog Number 03.161.053
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2016
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Patient identifier and weight were not available for reporting. Device is an instrument and is not implanted/explanted. A device history record review was performed for the subject device lot. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. The subject device has been received and is currently in the evaluation process. 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 during an anterior lumbar interbody fusion (alif) procedure at levels l5-s1 on (b)(6) 2014, the awl broke in the l5 anterior vertebra during the process of making a second pilot hole through the threaded drill guide which was attached to the implant. A drill was used for third and fourth holes. There was a one to two minute surgical delay due to extra time needed to retrieve the broken awl tip. No adverse event was reported. The patient postoperative status was reported as "stable". This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
Patient identifier and weight are unknown. Product investigation summary: the following complaint device was received for evaluation: awl (part: 03. 161. 053, lot: 7657546). Upon visual inspection of the instrument, the complaint condition was confirmed as the distal tip of the instrument has sheared off from the rest of device and was not returned (the tip is approximately 36. 2 +/- 0. 2 mm in length per product drawing). The balance of the device appears to be in good condition. The balance of the device appears to be in good condition. While the root cause is likely a result of the method of use, the specific conditions at the time of the issue are unknown, so the exact root cause cannot be definitively determined. The awl is part of the antegra instruments and implant set. The awl is used to perforate the cortical shell of the vertebral body in preparation for screw insertion. A device history record (dhr) review was performed for the part. No non-conformance reports were generated during production that would relate to the complaint condition. A review of the current design drawing for the instrument was performed. During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition. The returned parts were determined to be suitable for their intended use when employed and maintained as recommended. During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition. 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 NameAWL
Type of DeviceAWL
Manufacturer (Section D)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer (Section G)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer Contact
terry callahan
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5620034
MDR Text Key44050444
Report Number1719045-2016-10366
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.161.053
Device Lot Number7657546
Other Device ID Number(01)10705034711706(10)7657546
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2014
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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