MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ROD 4TH BLADE 3MM OFFSET; RETRACTOR

Catalog Number 8734-4134

Device Problem Bent (1059)

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

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that an offset blade bent during surgery while trying to retract an extremely tight iliac muscle.The instrument was used to complete the procedure without reported patient impacts.

Manufacturer Narrative

The returned device was evaluated.The rod holder was bent.There were no other signs of damage on the device.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper device usage.The patient was of large build causing excessive force to be placed on the device during use resulting in the device bending.

Event Description

It was reported that an offset blade bent during surgery while trying to retract an extremely tight iliac muscle.The instrument was used to complete the procedure without reported patient impacts.

• Brand Name: ROD 4TH BLADE 3MM OFFSET
• Type of Device: RETRACTOR
• 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: 7530853
• MDR Text Key: 108860634
• Report Number: 3012447612-2018-00426
• Device Sequence Number: 1
• Product Code: GAD
• 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
• Report Date: 10/24/2018

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: 8734-4134
• Device Lot Number: TU01769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 10/23/2018
• Supplement Dates FDA Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2017
• 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: 52 YR