MAUDE Adverse Event Report: BIOMET MICROFIXATION 90 DEGREE CONTRA ANGLE DRIVER; SCREWDRIVER

Model Number N/A

Device Problems Device Inoperable (1663); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Medical product: biomet microfixation ribfix blu temporary fixation screw catalog #: 76-0017 lot #: ni.Therapy date: (b)(6) 2018.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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00096.

Event Description

It was reported the driver that would not release the pin was used on a difficult location on the third rib.The surgeon attempted to release the pin several times, but ultimately had to pull the driver and pin from the bone which resulted in the bone being stripped.The second driver that was used would not turn the screw.There was a delay of approximately 10-15 minutes as another set was opened.The procedure was completed successfully using back-up drivers from another set.No additional patient consequences were reported.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Visual inspection and functional testing could not be performed due to the parts not being returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00096-1.

• Brand Name: 90 DEGREE CONTRA ANGLE DRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 7282413
• MDR Text Key: 100430913
• Report Number: 0001032347-2018-00095
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK142823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• 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: 24-1189
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00841036123130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2018
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention