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 Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Udi -- (b)(4).Two potential lot numbers have been provided.The initial reporter was not able to conclusively identify which lot was affected.If additional information is received upon product return, this report will be updated.It has been reported that the device will be returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the company representative, during a craniotomy procedure a perforator failed to disengage.The first hole was performed and the surgeon was able to get the bone off allowing him to remove the bit.The dura was almost torn but pushed inward; therefore, the patient suffered no injury.However, the hole was directly over the sylvian fissure and if the dura remained adherent to the skull, it would have likely resulted in a fatal or disabling injury to the middle cerebral artery.

Manufacturer Narrative

Udi: (b)(4).Sample was received for evaluation.The sample was visually inspected.The perforator was soiled and the label was destroyed.The perforator was then functionally tested.A series of holes with drilled without issue.A review of manufacturing records found no anomalies during the manufacturing process.Based on the results of the investigation, the reported issue could not be confirmed.The device performed as intended.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8115283
• MDR Text Key: 128758432
• Report Number: 1226348-2018-10835
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 26-1221
• Device Lot Number: J02T59
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other