MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE REAMER 8.0 MM DIAMETER; TRAUMA, INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign: event occurred in (b)(6).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.Product not returned.

Event Description

It was reported that the flexible reamer fractured during intramedullary reaming.The broken part was retained by the patient.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: a4, b3, b4, b5, b7, g4, g7, h1, h2, h6, h10 corrected data: event date is (b)(6) 2020 and not (b)(6) 2019 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h1, h2, h6, h10.D4 - lot number - previously reported lot number is incorrect.Correct lot number is unknown at this time.Reported event was confirmed by review of x-rays provided, which indicated an intramedullary rod with metallic fragments along the proximal to mid tibial diaphysis.Fractures were noted along the distal tibial diaphysis in the distal fibular diaphysis.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.A summary of the investigation has been sent to the complainant.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 further event information available at the time of this report.

• Brand Name: FLEXIBLE REAMER 8.0 MM DIAMETER
• Type of Device: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10927215
• MDR Text Key: 218919329
• Report Number: 0001822565-2020-03871
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00222800800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 26 YR
• Patient Weight: 55