MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RECON BONE PLATE STRAIGHT 3.5 MM 10 HOLES; PLATE, FIXATION

Model Number 1179-05-10

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned by hospital.

Event Description

It was reported that the patient underwent a revision procedure approximately five months post initial surgery due to left clavicular plate fracture and pain in her left shoulder.No additional patient consequences were reported as a result of the event.

Manufacturer Narrative

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.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.

Event Description

No additional event information is available at the time of this report.

• Brand Name: RECON BONE PLATE STRAIGHT 3.5 MM 10 HOLES
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11529445
• MDR Text Key: 241064702
• Report Number: 0001822565-2021-00683
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024034600
• UDI-Public: (01)00889024034600(11)181012(10)64201790
• Combination Product (y/n): N
• PMA/PMN Number: K142836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1179-05-10
• Device Catalogue Number: 00117900510
• Device Lot Number: 64201790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR