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 Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).The device has been returned for evaluation.Upon completion of the investigation.A follow-up report will be submitted.

Event Description

It was reported that the perforator failed to disengage and product came out from the drill and got stuck in the bone when the surgeon made the craniotomy.Therefore, the surgeon enlarged the craniotomy range, and removed it from the patient.The dura was not damaged, but the product approached to the limit.No further information was provided by hospital.The product will be returned to your site.

Manufacturer Narrative

The device was returned for evaluation.The perforator was visually inspected.No anomalies were observed, other than a missing product label.Functional testing was then performed.A series of holes were drilled per the test method without issue.A review of manufacturing records could not be performed, as no lot number was provided.Based on the investigation, the reported issue could not be found.The device functioned as intended.Trends will be monitored for this and similar issues.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: 7642815
• MDR Text Key: 112497131
• Report Number: 1226348-2018-10442
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Date Manufacturer Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR