MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ARTICULATING ARM LATERAL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
Event or Problem Description
It was reported that while the arm was being set up, the surgeon was turning the black knob to lock it and it made a loud pop.The arm would not tighten after that.The surgeon was able to make the arm work for the surgery without delay or impact to the patient.
Event or Problem Description
It was reported that while the arm was being set up, the surgeon was turning the black knob to lock it and it made a loud pop.The arm would not tighten after that.The surgeon was able to make the arm work for the surgery without delay or impact to the patient.
Additional Manufacturer Narrative
Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.This report is relaying additional information.Device evaluation: visual inspection revealed no signs of damage.A functional test was performed by attempting to tighten the arm by turning the black knob and found that it is frozen.Potential cause this event could possibly be attributed to wear through use over time or multiple sterilization cycles.It could also be attributed to applying excessive forces during previous tightening, which could cause damage to the internal mechanisms, preventing further use.Dhr review and related actions 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.

• Brand Name: ARTICULATING ARM LATERAL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 12044316
• Report Number: 3012447612-2021-00202
• Device Sequence Number: 17099034
• Product Code: LXH
• UDI-Device Identifier: 00888480667513
• UDI-Public: (01)00888480667513(10)IG23308
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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: 8734-0020
• Device Lot Number: IG23308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 06/29/2021
• 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 Weight: 113