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

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

Rep reported that the hospital believes there is a faulty batch of perforators as the same lot number was involved in 3 patient related events.The perforator failed to stop resulting in 1 dura tear.Customer is sending back (b)(4) unused devices for investigation.Customer requested replacement.Product associated with the patient events will not be returned for investigation.Related complaints: (b)(4).Requested dhr review from symmetry for complaints (b)(4).Used product (3) will not be returned for evaluation.All three perforators have the same lot # hg013s.

Manufacturer Narrative

(b)(4).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

The customer was contacted regarding product return and advised that the subject perforator is not available for evaluation.As such it is not possible to perform an evaluation of the product and determine the root cause of this complaint.The supplier reviewed the device history records and determined that this perforator (lot hg013s) met all tests associated with the assembly process and required specifications.We will continue to monitor for this or similar complaints for this product code.At this time this complaint is considered to be closed.Device not returned.

Manufacturer Narrative

Update: note the "faulty" perforators were not returned for evaluation.However; supplier evaluation of the 15 unused perforators did not verify the complaint.The customer's perforator met functional test acceptance requirements; proper engagement and disengagement was achieved with every drilled hole.Device history records show all tests and inspections, including a drilling test on each perforator, met specification requirements.The customer's perforator met functional test acceptance requirements; proper engagement and disengagement was achieved with every drilled hole.The supplier reviewed the device history records and determined that this perforator (lot hg013s) met all tests associated with the assembly process and required specifications.

• 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 Key: 4117882
• MDR Text Key: 20292509
• Report Number: 1226348-2014-12007
• 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: 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

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: HG013S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2014
• 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