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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC.

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CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC. Back to Search Results
Catalog Number 26-1221
Device Problem Failure to Auto Stop (2938)
Patient Problem Tissue Damage (2104)
Event Type  Injury  
Manufacturer Narrative
(b)(4).The customer advised that the perforator will not be returned.As such it is not possible to evaluate the product and determine the root cause of this complaint.Furthermore, the lot number for the subject product was not reported; therefore, the lot history records cannot be reviewed.We will continue to monitor for this or similar complaints for this product code.At this time this complaint is considered to be closed.
 
Event Description
As reported, in an earlier event, a perforator failed to stop resulting in a dural plunge.The rep has no further information on the event and the customer did not save the perforator.
 
Manufacturer Narrative
It was previously reported that the device would not be returned for evaluation.The device was subsequently returned.The device was returned and evaluated.The perforator was visually inspected and was found to have exhibited damage to the sleeve.Functional testing was performed through drilling a series of holes.No issues were found.The device functioned as intended.A review of manufacturing records could not be performed, as no lot number was provided.Based on the results of the investigation, the reported issue could not be confirmed.The device functioned as intended.Trends will be monitored for this and similar complaints.At present, we consider this complaint to be closed.
 
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Brand Name
CODMAN DISPOSABLE PERFORATOR
Type of Device
DRILLS, BURRS, TREPHINES & ACC.
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
new bedford industrial park
new bedford MA 02745
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6973783
MDR Text Key90105591
Report Number1226348-2017-10788
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K791101
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number26-1221
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/05/2017
Initial Date FDA Received10/24/2017
Supplement Dates Manufacturer Received04/02/2018
Supplement Dates FDA Received04/18/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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