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 Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

(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 during use the device was dull.When the surgeon tried to make the hole, the device became unable to perforate.About a quarter of the bone was left.There was no surgical delay and there was no adverse consequence to the patient.No further information was provided by hospital.

Manufacturer Narrative

(b)(4).The perforator was returned for evaluation.The device was visually inspected; no anomalies were found.The device had heavy damage to the plastic sleeve and required resleeving prior to functional testing.Once resleeved, the unit completed a series of five holes and was found to have performed as intended.A review of manufacturing records was not possible, as the lot number on the damaged sleeve was not legible.Based on the results of the investigation, the reported issue could not be confirmed.The device functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

A previous report stated in error that a review of manufacturing records was not possible.A manufacturing review was performed and no discrepancies were identified.This report has been updated with the corrected information.

• 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: 7415160
• MDR Text Key: 105377395
• Report Number: 1226348-2018-10263
• 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,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 26-1221
• Device Lot Number: HA3871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1