MAUDE Adverse Event Report: CONMED LINVATEC MCLASS OSCILLATING SAW BLADE 19MM X 1.19MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number TN190-119-05

Device Problems Peeled/Delaminated (1454); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Three (3) mclass oscillating saw blades were returned in the original packaging.Visual inspection by the packaging engineer confirmed that two (2) of the sterile packages were not sealed during the manufacturing process, and the third pouch had a slight mark on it indicating that the seal process was started, interrupted and not completed.A review of the device history records shows that this lot was manufactured on april 21, 2015 and (b)(4).The (b)(4).There were no discrepancies noted during the manufacturing process.A review of complaint history for this device and lot number combination shows there have been no other complaints received.A two-year review of complaint history for this device inclusive of all manufactured lots shows that there have been no similar complaints received.The product insert contains the following warning: do not use equipment if, upon receipt, package is opened, damaged, or shows any signs of tampering.Examination of the product occurs multiple times prior to use.This includes during shipping/receiving, distribution, storage and immediately prior to use.Good clinical practice includes examination and verification of the original packaging and its labeling to ensure both are intact prior to use.

Event Description

The international distributor in (b)(4) reported that during receiving and inspection of incoming products, a packaging defect was found.According to the distributor's inspection report, three (3) mclass oscillating saw blade packages were observed to have a seal that was peeling.Manufacturer inspection results confirmed that the three (3) returned packages failed visual inspection on (b)(4) 2015.There was no patient involvement, as the seal issue was discovered prior to distribution to an end user.

• Brand Name: MCLASS OSCILLATING SAW BLADE 19MM X 1.19MM
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer (Section G): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 5180859
• MDR Text Key: 30051858
• Report Number: 1017294-2015-00054
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: TN190-119-05
• Device Lot Number: 643984
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1