MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISP PERFORATOR 11MM; DRILLS, BURRS, TREPHINES & ACC.

Catalog Number 26-1222

Device Problems Fracture (1260); Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Udi - (b)(4).It has been reported that the device will be returned for evaluation.Upon receipt of additional relevant information, a follow-up report will be submitted.

Event Description

It was reported that the perforator was dull and broke into pieces during use.A decompressive craniectomy was being performed on a fall patient, the emax2 plus system was being used together with csr-60 and codman perforator (26-1222).About 30 minutes into the surgery, the system was used to perforate the skull.After several attempts (making several holes), none of the holes would perforate the skull.Less than half of the skull thickness were being cut, and after 15 minutes of trying, the perforator broke into two separate pieces.And the surgical team proceeded with hand operated burr after that.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Udi : (b)(4).The device was returned for evaluation.The perforator was visually inspected: the device was received disassembled and without a spring.It was also found that the hudson-end side of the green plastic sleeve exhibited damage (deformation) that is not associated with the manufacturing process.Due to the condition of the device as it was received, no functional testing was possible.The unit was then reassembled using a new spring, bearing and green sleeve.The resleeved unit was then tested by drilling a series of holes.The device functioned as intended.No issues were found.A review of manufacturing records found no discrepancies when the device was released to stock.Based on the results of the investigation, it was confirmed that the device was damaged; however, with the information available, the root cause could not be determined.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CODMAN DISP PERFORATOR 11MM
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7663746
• MDR Text Key: 113207194
• Report Number: 1226348-2018-10487
• 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,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 26-1222
• Device Lot Number: JH004S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Date Manufacturer Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1