• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Upon completion of the investigation a follow up report will be filed.
 
Event Description
As reported by the ous affiliate, when making a trepan hole, a perforator would not release.Operation lengthened by 20 minutes.
 
Manufacturer Narrative
The affiliate was contacted regarding product returned; however, the product was not returned for evaluation.As such it is not possible to evaluate the product and determine the root cause of this complaint.We will continue to monitor for this or similar complaints for this product code.A review of the lot history records did not show any anomalies during the manufacturing process.At this time this complaint is considered to be closed, should the product be returned at a later date this complaint will be re-opened and an investigation will be performed.
 
Manufacturer Narrative
Upon completion of the investigation it was noted that the unit was visually inspected utilizing unaided eye.No anomalies were observed.Unit was found to performed as intended.Unit completed testing (5 holes) and was found to performed as intended.The dhr (pn: 261221_bn: h60844) was reviewed and it was verified that there were no anomalies during the manufacturing process.Complaint could not be verified.Unit was found to meet all acceptance criteria.
 
Manufacturer Narrative
Device was returned for evaluation.A follow up report will be filed upon completion of the investigation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6878598
MDR Text Key87197370
Report Number1226348-2017-10681
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,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup,Followup
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 Catalogue Number26-1221
Device Lot NumberH60844
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/25/2017
Initial Date FDA Received09/20/2017
Supplement Dates Manufacturer Received09/26/2017
11/27/2017
01/15/2018
Supplement Dates FDA Received10/12/2017
11/27/2017
01/22/2018
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
-
-