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 Problems Cerebrospinal Fluid Leakage (1772); Tissue Damage (2104)

Event Date 11/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

As reported by the ous affiliate, a perforator did not disengage.After extraction, a csf flow and bleeding are seen.An enlargement of the cranium, an enlarged opening of the dura mater and a coagulation of the blood vessels were performed.The haemostasis is completed by a dura mater plasty with pericranium, the suture is leakproof so they continued the gesture initially planned.At the end of the procedure, the patient responds to stimuli in an appropriate way and moves the 4 limbs.

Manufacturer Narrative

A review of the dhr was completed; the provided lot number is not a valid lot number for perforators and no review could be completed.No complaint sample was returned, therefore no failure investigation could be conducted.A review of the december complaint trending and smt was conducted, the neurodisposal family has been below the ucl and no anomalies are evident in the tecomet or raynham perforator families.We are still awaiting the return of the product.Once it is received, a followup report will be filed.3.

Manufacturer Narrative

It was previously reported that the device would be returned for evaluation, however the device was not made available.If the device is returned in the future, the complaint will be re-opened and a follow-up report will be filed.At the present time this complaint is considered closed.

Manufacturer Narrative

The device was returned for evaluation.The perforator was visually inspected.The unit was found to have damage unrelated to the manufacturing process on both the tines and the outer drill, as well as on the largest outer diameter of the blue sleeve.Functional testing was performed.A series of holes were drilled without issues.The device functioned as intended.A review of manufacturing records could not be performed, as the lot number provided is not valid for this part number.Based on the results of the investigation, the reported issue could not be confirmed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

It was previously reported that the device would not be returned.The product was subsequently provided.Upon completion of the investigation, a follow-up report will be submitted.

• 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: 7133407
• MDR Text Key: 95342143
• Report Number: 1226348-2017-10991
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• 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: HH35345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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