MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE CANNULATED REAMER 6 MM DIAMETER; INSTRUMENT, EXTREMITIES

Catalog Number 00840107202

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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

It was reported during the initial total elbow replacement the reamers broke near the top of the shaft outside the bone.The case was completed with other reamers in the tray.This was the initial use of that particular reamer during that case and no delay was caused.All pieces were retrieved and no harm to the patient.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A flexible cannulated reamer was returned for evaluation.Visual examination of the returned product identified shaft and the rod were disassembled.The device has 6 years of field age and it is unknown how many times the device was used.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.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 CANNULATED REAMER 6 MM DIAMETER
• Type of Device: INSTRUMENT, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10263087
• MDR Text Key: 198525797
• Report Number: 0001822565-2020-02508
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00840107202
• Device Lot Number: 62651934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Age: 69 YR