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

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.

• 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 Key: 3918424
• MDR Text Key: 4518261
• Report Number: 1226348-2014-11799
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK791101
• Number of Events Reported: 1
• 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 Number: 26-1221
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/13/2014
• Initial Date FDA Received: 07/08/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/10/2014; 08/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR