MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ZYSTON 8MM PADDLE SCRAPER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 14-533208

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that a paddle shaver was bent during surgery.The procedure was completed with this device.There were no reports of patient impacts associated with this event.

Manufacturer Narrative

The returned paddle scraper was evaluated.The tip was found to have been bent/twisted.The cause can likely be attributed to greater than usual applied torsional force due to an obstruction in the scraper's path.A review of the dhr did not identify any issues which would have contributed to this event.

Manufacturer Narrative

Additional information: lot number, conclusions - current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

• Brand Name: ZYSTON 8MM PADDLE SCRAPER
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7033703
• MDR Text Key: 93038099
• Report Number: 3012447612-2017-00653
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 14-533208
• Device Lot Number: ZB161001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 11/30/2017; 07/05/2018
• Supplement Dates FDA Received: 12/20/2017; 08/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR