MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCORD FLUSH CUTTER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	71360024
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during cutter would not cut, creating shards of cable in the wound.No injuries or delays reported.Backup device available.No more information provided yet.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.We recommend that all re usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re opened.

• Brand Name: ACCORD FLUSH CUTTER
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8844193
• Report Number: 1020279-2019-02865
• Device Sequence Number: 1412888
• Product Code: JDG
• UDI-Device Identifier: 03596010485397
• UDI-Public: 03596010485397
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2019

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: Health Professional
• Device Catalogue Number: 71360024
• Device Lot Number: 09HM01328
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/06/2019
• Supplement Date Received by Manufacturer: 07/06/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 11/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1