MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CABLE FOR BONE PLATE 1.8 MM DIAMETER 24 IN. (610 MM) LENGTH; PLATE, FIXATION

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 02/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: plate, catalog#:00223200302, lot#:62320940.It is unknown if this device will be returned for analysis; however, an investigation has been initiated for this event.Upon completion of the investigation, a follow up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 01858.

Event Description

It was reported that during a femoral plating procedure, the cable holes in the plate were too small to allow the cable to pass.The plate was already fixed to the patient with screws and the surgeon did not want to remove it so he used cerclage wires to complete the procedure.There was a 1 -2 hour delay in the procedure reported.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: CABLE FOR BONE PLATE 1.8 MM DIAMETER 24 IN. (610 MM) LENGTH
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6926648
• MDR Text Key: 88917179
• Report Number: 0001822565-2017-06776
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: PK151716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00223200318
• Device Lot Number: 62851739
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR