MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PROBE, LUMBAR, STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	730M1001
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned probe was evaluated the complaint is confirmed for the vital probe for the reported failure of bent tip as well as the previously unreported failure of fractured tip.It was reported that the patient had hard bone which would add additional stress and forces onto the instrument, which likely led to it's failure.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.Labeling was reviewed and found to contain adequate instructions.
Event or Problem Description
It was reported that during the procedure the tip of the vital probe bent.There were no reported patient impacts and no further surgical information provided.However, device evaluation by zimmer biomet personnel found a portion of the tip has fractured off.

• Brand Name: PROBE, LUMBAR, STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10440004
• Report Number: 3012447612-2020-00497
• Device Sequence Number: 17158793
• Product Code: LXH
• UDI-Device Identifier: 00880304988507
• UDI-Public: (01)00880304988507(10)616943
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/21/2020

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: 730M1001
• Device Lot Number: 616943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1