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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC SKY SELF CENTERING AWL

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DEPUY SPINE INC SKY SELF CENTERING AWL Back to Search Results
Model Number 286820400
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.
 
Event Description
Self centering awl tip broke when pressure was applied to the anterior aspect of vertebral body.Patient consequence? no.
 
Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was not returned for evaluation.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.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 Name
SKY SELF CENTERING AWL
Type of Device
AWL
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
MDR Report Key7646509
MDR Text Key112898458
Report Number1526439-2018-50611
Device Sequence Number1
Product Code HWJ
UDI-Device Identifier10705034215372
UDI-Public(01)10705034215372
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number286820400
Device Catalogue Number286820400
Device Lot Number0406V
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/06/2018
Initial Date FDA Received06/28/2018
Supplement Dates Manufacturer Received07/24/2018
Supplement Dates FDA Received07/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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