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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 Clinical Signs, Symptoms or Conditions (4582)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Without a valid lot number the device history records review could not be completed. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Occupation: initial reporter is j&j company representative. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 europe reports an event in (b)(6) as follows: skyline self centering awl ((b)(4)) broke. Tip separated from handle, likely due to normal wear and tear. Happened after surgery, no impact on the surgery or patient. This complaint involves one (1) device. This report is for one (1) sky self centering awl. This report is 1 of 1 for (b)(4).

 
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Brand NameSKY SELF CENTERING AWL
Type of DeviceAWL
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham 02767
MDR Report Key11896456
MDR Text Key254578920
Report Number1526439-2021-01059
Device Sequence Number1
Product Code HWJ
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 04/30/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/27/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number286820400
Device Catalogue Number286820400
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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