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

Catalog Number 26-1221

Device Problem Material Discolored (1170)

Patient Problem No Information (3190)

Event Date 06/02/2015

Event Type  malfunction  

Event Description

Yesterday, disposable perforators (p/n:26-1221) were imported and we detected stains on some products.We have over 40 pieces of this issue.I have attached pictures.This was found during the incoming inspection in (b)(6).On (b)(6) 2015 per affiliate, "we detected another nc products for same issue, see attached mail.".

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Manufacturer Narrative

Upon completion of the investigation it was noted that the non-conformance for stains detected on hudson end (p/n 260-1220-20) of disposable 14mm perforator product (p/n 26-1221) was verified by (b)(4) only on hudson ends (and not on inner/outer drills) for the returned for the returned 5 pieces of perforator products; however, the true root cause was not confirmed.Most probable root causes to staining are improper rinse process leading to residual staining on perforator product as well as improper visual inspection process for detection of staining on product, this however could not be determined.Supplier corrective/preventive action: 1- revised perforator assembly manufacturing methods to include in-process visual inspection requirements for discoloration (stains/corrosion).2-created one point lesson (opl) to bring awareness to staining nc as well as to provide additional training tool to ensure proper visual inspection of staining during in-process assembly and packaging of perforator product.All perforator assembly operators as well as passivation operators will be trained to opl.Most probable root causes to staining are improper rinse process leading to residual staining on perforator product as well as improper visual inspection process for detection of staining on product, this however could not be determined.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• 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: 4862334
• MDR Text Key: 5850159
• Report Number: 1226348-2015-10366
• 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: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: EH006S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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