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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).(udi): n/a.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 a piece of the bolt cutter broke off during the procedure and the piece fell into the patient¿s wound.An x-ray was taken which revealed that the piece was inside the patient.The surgeon located the broken piece and removed it from the patient¿s wound.Attempts have been made and there is no additional information available at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Reported event was confirmed per visual inspection which shows one of the jaws fractured near the tip.X-rays were received however they were not sent for review as it would not enhance the investigation.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SPINAL ROD CUTTER MAXIMUM PIN DIAMETER 6.4 MM (1/4 IN.)
• Type of Device: INSTRUMENT SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10472991
• MDR Text Key: 205085739
• Report Number: 0001822565-2020-03081
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00392500200
• Device Lot Number: 63647253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 74