MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POSTERIOR BLADE LATERAL RETRACTOR 130MM

Catalog Number 8734-5130

Device Problems Crack (1135); Disassembly (1168)

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

Event Date 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.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 the blade of an assembly cracked, which allowed the shim to disassemble from the blade assembly during surgery.The blade and shim were removed from the wound.The blade assembly was not needed to complete the rest of the procedure.There were no reports of patient impacts associated with this event.

Manufacturer Narrative

The returned blade assembly was evaluated.The blade was found to have cracked, which allowed the shim to disassemble from the blade.The cause is likely attributed to impaction forces placed on the device while attempting to insert the shim into the disc space.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: POSTERIOR BLADE LATERAL RETRACTOR 130MM
• 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: 6872742
• MDR Text Key: 86482430
• Report Number: 3012447612-2017-00509
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8734-5130
• Device Lot Number: TU00601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2014
• 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