MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. HF PLUG DRIVER; NEXTGEN ALTIUS OCT SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that a plug driver broke during final tightening.There was no reported impact on the patient.
Additional Manufacturer Narrative
Correction in b3.Additional information in h6: investigation type, findings, and conclusions.Device evaluation: product not returned and photos were not provided for review, so device evaluation could not be performed.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.It could also be attributed to off-axis forces applied during use.Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that a plug driver broke during final tightening.There was no reported impact on the patient.

• Brand Name: HF PLUG DRIVER
• Common Device Name: NEXTGEN ALTIUS OCT SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11832759
• Report Number: 3012447612-2021-00177
• Device Sequence Number: 3202409
• Product Code: KWP
• UDI-Device Identifier: 00888480594772
• UDI-Public: (01)00888480594772(10)PW38N
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K113593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-525037
• Device Lot Number: PW38N
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 70