MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PEG DRIVER FAST 2.0MM; INSTRUMENT/TRAUMA

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01986, 0001825034-2021-01987, 0001825034-2021-01988.Medical products: item#: fpd20, peg driver fast 2.0mm; lot#: dbw271660; item#: fpd20, peg driver fast 2.0mm; lot#: 284671; item#: fpd20, peg driver fast 2.0mm; lot#: 284681; item#: mqc, handle mini quick connect; lot#: 879284.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.

Event Description

It was reported that during a surgical procedure the instrument fractured during removal.

Event Description

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

Manufacturer Narrative

Cmp-0707031 this follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01986-1 0001825034-2021-01987-1 0001825034-2021-01988-1.Lot 284681: sem analysis of the peg driver sample showed that the fracture surface was excessively smeared and did not reveal any artifacts that suggests a failure mode.Eds semi-quantitative elemental analysis of the peg driver sample showed that it was consistent with 440 stainless steel.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot 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.

• Brand Name: PEG DRIVER FAST 2.0MM
• Type of Device: INSTRUMENT/TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12128898
• MDR Text Key: 260297589
• Report Number: 0001825034-2021-01989
• Device Sequence Number: 1
• Product Code: HWR
• 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: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: FPD20
• Device Lot Number: 284671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 09/01/2021
• Supplement Dates FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1