MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CRANIOPLASTIC; METHYL METHACRYLATE FOR CRANIOPLASTY

Catalog Number 43-1280

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

There is some unknown powder in package.3/8/2016 per affiliate: did this event occur intra-operatively? this event occurred intra-op.Did the reported event cause any delays in surgery over 30 minutes? no.Were there any adverse consequences to the patient? no.What actions were taken as a result of this incident? there are other cranioplastic kits in or stock, they used new one.Is the device being returned for evaluation? i will update shipment number once i received the sample.Please provide the name of the institution involved in this incident.(b)(6) hospital only.Please provide the date you were notified of this event.Thursday, march 3 rd 2016.Was the reported contamination found inside or outside of the sterile barrier? the unknown powder was found inside sterile pack.

Manufacturer Narrative

(b)(4).From the complaint description and photographs provided, it appears the inner package containing the cement powder has not fully sealed properly.There is a hole in the seal approximately 5mm wide with the entire seal length being 80mm, results in the seal being approximately (b)(4) defective.A device history review has been conducted and this issue has not been raised in the past 12 months for this product.The cement powder is manually filled into the packages and sealed manually using a bosch sealer which is checked against sealing specification limits prior to production commencement, for temperature and speed settings, to ensure the sealer is working effectively.The powder bags are then placed in a secondary package and sent for externally sterilisation.On return, they are checked and placed into a foil package before final packing into a unit carton.As all of these processes are manual, there are numerous checks conducted hence many opportunities for leaking cement powder to be detected.Therefore the seal most likely became defective post final packing.The operators have been briefed on this issue.The dfmea has been reviewed and it gives reference to open seals, stating how the integrity of the cement powder bag packaging over the course of the shelf life has been assessed during stability studies.The number of complaints for this issue will be monitored going forward and if an upward trend arises then the sealing specifications and packaging processes will be reviewed.A complaint database search finds no additional reports against the provided product and lot combination.Based on the inability to find any other related incidents against the provided product and lot code, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: CRANIOPLASTIC
• Type of Device: METHYL METHACRYLATE FOR CRANIOPLASTY
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5529528
• MDR Text Key: 41270708
• Report Number: 1226348-2016-10234
• Device Sequence Number: 1
• Product Code: GXP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK071791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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: 03/28/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 43-1280
• Device Lot Number: 8050190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2016
• 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