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

Catalog Number 26-1221

Device Problem Dull, Blunt (2407)

Patient Problem No Information (3190)

Event Date 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

Gtin: (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 available.

Event Description

We had another perforator fail us during surgery today.The lot# was gg12s.Clinician is beyond the point of concern at this point and wants us to start looking at other suppliers of perforators.As you understand when this perforator isn't working properly our patients are at a significant risk for injury.Clinician wants a reply from you as to how this won't happen again.Are each one of these perforators tested for reliability before sterilization and packaging? if not why? (b)(6) 2015: "clinician told me they just keep drilling for like 5 minutes at least and not making much progress.He is also worried if perforator may keep drilling and drill too deep.He said he has been using these forever and never had problems.I spoke with him in person this past friday and he said he thought maybe it was just a bad lot.I made sure they knew that each one was tested before sterilization.A lot of these cases are dbs cases where patient is awake.He wants to look at other vendors now.".

• 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: 5068696
• MDR Text Key: 25665194
• Report Number: 1226348-2015-10511
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: GG12S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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