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U.S. Department of Health and Human Services

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

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CODMAN & SHURTLEFF CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC. Back to Search Results
Catalog Number 26-1221
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2014
Event Type  Injury  
Event Description
The device in question was used for the patient who was (b)(6) old female.During the operation, the surgeon found that the seal of the device came off.It is noted that no problem was found in pre-use inspection.Details will be informed as soon as (b)(6) receive them from the facility.(b)(4) 2014 additional questions have been asked to clarify what is meant by the "seal".It is our belief that they may be referring to the label.As a result according to the matrix the complaint would be reportable by serious injury as potential foreign body reaction, or medical intervention to prevent injury could have occured.
 
Manufacturer Narrative
Upon completion of investigation, a follow up report will be filed.
 
Manufacturer Narrative
Evaluation of the perforators (2) revealed that 1 perforator is missing the label.There is evidence of adhesive residue and some label material here the label was affixed.The presence of the adhesive indicates that the label was affixed to this instrument at one time.The exact cause of removal of the label could not be verified; however, it appears that the label was pulled off the instrument purposely.It is likely that the label was lifted/pulled off of the instrument in the clinical setting; however, this could not be verified.The reported "the seal of the device came off" is associated with user misuse and is not attributed to manufacturing defects.These labels are securely affixed during the manufacturing process and inspected prior to placing perforator in inventory.The second perforator has the label securely attached, the edges are not lifted or show evidence of an attempt to remove the label.The lot code ag 012s is clearly visible on the label.There were no other anomalies noted on either instrument.The cutting surfaces appear to be free of nicks or dents.The device history records for this perforator were reviewed.All assembly process tests and inspection associated with the assembly process, met specification requirements.Trends will be monitored for this and similar complaints.At the present time, this complaint is considered closed.
 
Event Description
Additional information stated: on 7/16/2014: we have not received the additional information yet.Since we have received the device today, we will ask the rep for further information.Regarding the seal, yes, that refers to the label on attached to the sleeve of the device.
 
Manufacturer Narrative
It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information 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.
 
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Brand Name
CODMAN DISPOSABLE PERFORATOR
Type of Device
DRILLS, BURRS, TREPHINES & ACC.
Manufacturer (Section D)
CODMAN & SHURTLEFF
new bedford industrial park
new bedford MA 02745
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key3918424
MDR Text Key4518261
Report Number1226348-2014-11799
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 Foreign,Company Representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,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
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/13/2014
Initial Date FDA Received07/08/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received07/10/2014
08/14/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2013
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
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