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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 Device Operational Issue (2914)
Patient Problem No Information (3190)
Event Date 04/19/2016
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4).Upon completion of the investigation a follow up report will be filed.
 
Event Description
A disposable perforator was sent to codman from stryker instruments, (b)(4) with the following event details: "the perforator came off from the perforator chuck when the surgeon tried to pull the perforator out from the patient, then the perforator remained on the patient.Then our service staff tested it using demo units.Then he found that using the older chuck, s/n (b)(4) did not replicate the same failure but the newer one s/n (b)(4) could replicate the same failure, then he checked the perforator chucks and found the position of the ball retainer was different.It is likely the design change was done in 2008 by checking the drawing.Update 12-may-2016: the perforator bit was not retained - there was no adverse consequences for the patient in this event.".
 
Manufacturer Narrative
(b)(4).Upon completion of the investigation it was noted that the customer's complaint was not verified.The customers¿ perforator met functional test acceptance requirements; proper engagement and disengagement was achieved with every drill hole, and there was no erratic or poor cutting action.The device history records (perforator assembly) show all tests and inspections, including a drilling test on each perforator, met specification requirements.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is 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 Key6013532
MDR Text Key56980988
Report Number1226348-2016-10716
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 foreign
Reporter Occupation Other
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? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number26-1221
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/16/2016
Initial Date FDA Received10/10/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2016
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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