MAUDE Adverse Event Report: BIOMET MICROFIXATION "1.5MM" SYSTEM SCREWDRIVER BLADE

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Report source: foreign country - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during a trauma case where the patient had massive facial injuries the screw driver blades were not picking up or retaining the screws.The blades were worn out and were not picking up the screws or the screws would fall off the blade into the wound.Removal of the fallen screws can be challenging when working through small openings and it can be extremely difficult to retrieve the fallen screws.The surgeon called the sales representative during the case to request he urgently bring new blades.The duration of the surgical delay is unknown.No additional patient consequences were reported.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Functional testing and inspection of the blades and screws could not be performed because they were not returned.Three attempts were made for additional information and product return with no new information yielded including the part number of the screws.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.

• Brand Name: "1.5MM" SYSTEM SCREWDRIVER BLADE
• Type of Device: BLADE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7587866
• MDR Text Key: 110642458
• Report Number: 0001032347-2018-00356
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: PK121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• 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: 01-7176
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00841036013332
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWS CATALOG #: NI LOT #: NI; UNKNOWN SCREWS CATALOG #: NI LOT #: NI
• Patient Outcome(s): Required Intervention