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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 Dull, Blunt (2407)
Patient Problem No Information (3190)
Event Date 08/19/2015
Event Type  malfunction  
Manufacturer Narrative
Gtin: (b)(4).It has been communicated that the device is not available for evaluation.Without the device it is not possible for codman to conduct a proper investigation.Since a lot number has been provided a review of the manufacturing records will be reviewed.We anticipate that the evaluation will reveal that the device conformed to specifications prior to release.If anything otherwise is found then a follow up report will be filed.If at some point the device does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.Device not available.
 
Event Description
We had another perforator fail us during surgery today.The lot# was gg12s.Clinician is beyond the point of concern at this point and wants us to start looking at other suppliers of perforators.As you understand when this perforator isn't working properly our patients are at a significant risk for injury.Clinician wants a reply from you as to how this won't happen again.Are each one of these perforators tested for reliability before sterilization and packaging? if not why? (b)(6) 2015: "clinician told me they just keep drilling for like 5 minutes at least and not making much progress.He is also worried if perforator may keep drilling and drill too deep.He said he has been using these forever and never had problems.I spoke with him in person this past friday and he said he thought maybe it was just a bad lot.I made sure they knew that each one was tested before sterilization.A lot of these cases are dbs cases where patient is awake.He wants to look at other vendors now.".
 
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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 Key5068696
MDR Text Key25665194
Report Number1226348-2015-10511
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK791101
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number26-1221
Device Lot NumberGG12S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/10/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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