MAUDE Adverse Event Report: ZIMMER BIOMET, INC. T7 DRIVER CANNULATED AO; SCREW, FIXATION

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Mini ratchet handle ao, cat#:110017406 lot#: ni , hdls cmpn scr 2.5x22 ns, cat#:110018421 lot#: ni.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 scarf osteotomy to fix a hallux valgus, while seating the headless compression screw, the tip of the driver bent.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.Reported event was confirmed by review of provided photographs.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to plastic deformation as a result of the design of the device.These drivers have been designed to twist before fracture of the screw.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.Product location unknown.

• Brand Name: T7 DRIVER CANNULATED AO
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• 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: 7504636
• MDR Text Key: 107964118
• Report Number: 0001825034-2018-03302
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: PK142658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 110018531
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 51 YR