MAUDE Adverse Event Report: CONMED 10 X 35 X 0.6MM STERNUM SAW BLADE

Catalog Number	00505953200
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported 10 devices were returned to conmed for evaluation.A packaging engineer determined the sterility breach in 4 of the 10 devices.The protective sleeve of the device was caught in the chevron seal during the manufacturing process.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of this product.The products released for distribution were found to have met all specifications prior to shipment.This is the only complaint against this lot of (b)(4) units.A two-year historical complaint review revealed one similar complaint.In that same timeframe, (b)(4) units have been manufactured and sold worldwide, making the rate of occurrence of this confirmed failure (b)(4) percent.A risk analysis was performed and deemed acceptable.This reported packaging issue was obvious to the distributor, prompting the return of the device for evaluation.There was no patient involvement.As with all medical devices, examination of the product occurs multiple times prior to use.Good clinical practice would include examination and verification of the original packaging and its labeling to ensure both are intact.The instructions for use (ifu) provides the following warning.If packaging has been opened/damaged or altered, do not use the product and contact the manufacturer immediately.This incident type will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported ten 00505953200 blades' inner pouches were put in the seal area.This was found during incoming inspection, therefore, there was no patient contact.This complaint was reviewed and a regulatory rationale of "non-reportable" was documented.The reported devices were returned to conmed and r&d determined by way of dye leak testing there was a breach in sterility of 4 devices on 29-nov-2017.The regulatory rationale was updated to reflect the evaluation findings, deeming this a reportable event on (b)(6) 2017.This report is raised on the basis of a reported malfunction with potential for injury with recurrence.

• Brand Name: 10 X 35 X 0.6MM STERNUM SAW BLADE
• Common Device Name: BLADE
• Manufacturer (Section D): CONMED; 11311 concept blvd; largo FL 33773
• MDR Report Key: 7101726
• Report Number: 1017294-2017-00128
• Device Sequence Number: 1272577
• Product Code: GFA
• UDI-Device Identifier: 20845854006174
• UDI-Public: (01)20845854006174(17)220802(30)5(10)856401
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 08/02/2022
• Device Catalogue Number: 00505953200
• Device Lot Number: 856401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1