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 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

Udi - (b)(4).Attempts to obtain additional information are being performed.Upon receipt of new relevant information, a follow-up report will be submitted.Refer to mdr 1226348-2018-10667 for information regarding the second device reported in this event.

Event Description

It was reported that two perforator devices were dull and unable to cut the bone.It stopped cutting while drilling and could not perforated the bone.The product was replaced with another similar one but the same issue occurred with the product.The patient has a thick bone.There was no adverse consequence to the patient and no further information was provided by hospital reported.The products will be returned to your site.

Manufacturer Narrative

(b)(4).Two devices were returned for evaluation.The perforators were visually inspected.No anomalies were observed.Functional testing was then performed per the test method.A series of holes were drilled without issue.A review of the manufacturing records found no discrepancies when the devices were released to stock.Based on the results of the investigation, the reported issue could not be confirmed.The devices functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

A lot number has been provided.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

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

• 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: 7890249
• MDR Text Key: 120832436
• Report Number: 1226348-2018-10668
• 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,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 26-1221
• Device Lot Number: HX3796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1