MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PRECISION FLX RMR 8.5MM DISP; REAMERS

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 110004180 precision flx rmr 4.5mm disp 836380, 110004180 precision flx rmr 4.5mm disp 730470, 110004187 precision flx rmr 9.0mm disp 002290.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 reports: 0001825034 - 2018 - 04160, 0001825034 - 2018 - 04159, 0001825034 - 2018 - 04164.

Event Description

It was reported that during left knee acl reconstruction procedure, four (4) flexible reamers fractured at the distal and proximal ends.The fractured pieces were removed from the patient and the procedure was able to be successfully completed.

Manufacturer Narrative

The following report is being submitted to relay additional information received.Complaint sample was evaluated and the reported event was confirmed.Upon visual inspection of the returned devices shows fracture, sem analysis showed that it fractured due to bending overload.The fracture showed evidence of brittle overload.Post fracture damage was also observed on the fracture the edges appeared to have smeared as well.Eds material analysis showed the material was consistent with material specification.Review of device history records found these units were released to distribution with no related deviations or anomalies.It was noted that the patient had a tight femoral notch and, it was also confirmed that the wire outside the tunnel was straightened.Further, follow-ups during investigation determined the resident did not apply constant power but rather was starting/stopping during reaming.These are all factors which may have contributed to the event, however, 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 additional information is available to report at this time.

• Brand Name: PRECISION FLX RMR 8.5MM DISP
• Type of Device: REAMERS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7655072
• MDR Text Key: 112884172
• Report Number: 0001825034-2018-04162
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• 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: 110010578
• Device Lot Number: 024790
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention