MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PEDICLE PROBE - CURVED LUMBAR LENKE

Catalog Number	07.02072.001
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint is confirmed for 1 returned vitality curved lumbar lenke for the reported failure of bending/fracturing.Visual inspection revealed that the tip of the device has broken off.Per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any previous actions.No holds or recalls are associated with this part number.The damage to the device likely occurred during regular use and was a result of normal wear.However, 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 or Problem Description
It was reported that during the surgery, the probe became bent.While attempting to straighten the bent probe on the back table in the or, the tip broke off.There was no impact on the patient.

• Brand Name: PEDICLE PROBE - CURVED LUMBAR LENKE
• Common Device Name: PROBE
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10684628
• Report Number: 3012447612-2020-00582
• Device Sequence Number: 18975626
• Product Code: HXB
• UDI-Device Identifier: 00889024009943
• UDI-Public: (01)00889024009943(10)63040721
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2020

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 Catalogue Number: 07.02072.001
• Device Lot Number: 63040721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1