MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. TM T/PLIF INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	96-701-10001
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 surgeon experienced an issue where the tm ardis inserter would not detach after inserting the cage.There was a 10-minute delay but no reported patient harm.
Event or Problem Description
It was reported that a surgeon experienced an issue where the tm ardis inserter would not detach after inserting the cage.There was a 10-minute delay but no reported patient harm.
Additional Manufacturer Narrative
Corrections in d4: lot & udi numbers, d9, and h3.Additional information in h4.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that a surgeon experienced an issue where the tm ardis inserter would not detach after inserting the cage.There was a 10-minute delay but no reported patient harm.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in h3.Additional information in h6: investigation type, findings, and conclusions.A review of the dhr was conducted and found no indications of manufacturing issues.An inspection of the part revealed no signs of damage.A functional inspection was performed with an ardis implant which revealed the inserter was able to connect to the implant and release as expected.This event likely cannot be attributed to manufacturing or design related issues.The complaint is unconfirmed for ardis inserter for the failure of jamming.A definitive root cause cannot be determined as the returned device was found to function as expected.This device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: TM T/PLIF INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 23416567
• Report Number: 3012447612-2025-00335
• Device Sequence Number: 21434580
• Product Code: HWA
• UDI-Device Identifier: 00889024320543
• UDI-Public: (01)00889024320543(10)63667664
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2026

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: 96-701-10001
• Device Lot Number: 63667664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/21/2025; 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic