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

Lot Number GF001S

Device Problem Failure to Auto Stop (2938)

Patient Problem No Code Available (3191)

Event Date 09/10/2013

Event Type  Injury  

Event Description

The medwatch report stated that while drilling cranial burr holes, the perforator drill bit plunged after the burr holes was complete.The cranial bone was removed and the dura was opened.There were no vascular injuries.The perforator nicked the surface of the cortex.

Manufacturer Narrative

It has been communicated that the device is not available for evaluation.Without the device it is not possible for codman to conduct a proper investigation.Since a lot number has been provided a review of the manufacturing records will be reviewed.We anticipate that the evaluation will reveal that the device conformed to specifications prior to release.If anything otherwise is found then a follow up report will be filed.If at some point the device 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.Device not returned.

Manufacturer Narrative

Please be advised that the lot number is gf001s and not gf0001s as previously reported.It has been communicated that the device is not available for evaluation.Without the device it is not possible for codman to conduct a proper investigation.Since a lot number has been provided a review of the manufacturing records have been conducted and they revealed that the device conformed to all manufacturing and quality testing/inspection specifications prior to being released to stock.If at some point the device is returned for evaluation this complaint will be re-opened and investigated.Based on this evaluation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3585090
• MDR Text Key: 16453537
• Report Number: 1226348-2014-11176
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: GF001S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Report to Manufacturer: 01/14/2014
• Date Manufacturer Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR