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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 Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Attempts are being made to obtain additional information.Upon receipt of new, relevant information a follow-up report will be submitted.
 
Event Description
As reported by the affiliate, a perforator failed to disengage, with it jammed in the bone and injuring the dura.Issue occurred during drilling of the first hole.A blood transfusion was required, extending the treatment time.
 
Manufacturer Narrative
Additional event information has been provided.Upon receipt of new relevant information, a follow-up report will be submitted.
 
Event Description
As reported by the affiliate, a perforator failed to disengage, with it jammed in the bone and injuring the dura.Issue occurred during drilling of the first hole.A blood transfusion was required, extending the treatment time.The patient had no lasting harm from event.There was a significant delay over 30 minutes.The drill speed was about 1000-1300 tr/min.The target site used was occipital bone.The bone was 10 mm in thickness.The bone quality was normal and there was no increase in icp.The device was held perpendicular to the bone.The device was re-processed with phagoneutre.
 
Manufacturer Narrative
Udi: (b)(4).Sample was received for evaluation.The sample was visually inspected, no anomalies were observed.The perforator was then functionally tested.A series of holes with drilled without issue.The device performed as intended.A review of manufacturing records found no anomalies during the manufacturing process.Based on the results of the investigation, the reported issue could not be confirmed.Trends will be monitored for this or 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.
325 paramount drive
raynham MA 02767
MDR Report Key8161318
MDR Text Key130240516
Report Number1226348-2018-10883
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
PMA/PMN Number
K791101
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/07/2018
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? Yes
Device Operator Health Professional
Device Expiration Date05/31/2023
Device Catalogue Number26-1221
Device Lot NumberHY4634
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2019
Initial Date Manufacturer Received 12/07/2018
Initial Date FDA Received12/13/2018
Supplement Dates Manufacturer Received01/03/2019
02/14/2019
Supplement Dates FDA Received01/04/2019
02/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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