MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SPINAL ROD CUTTER MAXIMUM PIN DIAMETER 6.4 MM (1/4 IN.); WIRE, CUTTER

Catalog Number 00392500200

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a spine procedure, the instrument would not open leading to an hour delay.Another instrument was used to complete the procedure.

Manufacturer Narrative

The reported event could not be confirmed as evaluation of the returned product identified that the device performed as intended.Review of the device history record identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for this item as well as the reported part and lot combination.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information received.

• Brand Name: SPINAL ROD CUTTER MAXIMUM PIN DIAMETER 6.4 MM (1/4 IN.)
• Type of Device: WIRE, CUTTER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8197508
• MDR Text Key: 131441151
• Report Number: 0001822565-2018-07056
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00392500200
• Device Lot Number: 63594476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization