MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL SPINAL FUSION DEVICE SIZE 14X14, ANGLED 6MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source - foreign: (b)(6).The complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It is reported that when the nurse opened the fusion device, a piece of foreign debris that appeared consistent with cotton had adhered to the porous surface of the implant.No adverse effects were reported as a result of this event.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A trabecular metal tm-s fusion device was returned for evaluation.As returned, the white debris was no longer attached to the device at the time of the evaluation.A complaint out of box(coob) cannot be confirmed as the white material is likely from the garment.Tm-s is packaged in a foil pouch which has a green inner liner.Coob cannot be confirmed as the device returned does not contain any white material upon receipt.The dhr review indicates the devices were manufactured and packaged to specifications.Inspection documentation shows all devices that were accepted, completed, and sent to inventory met specifications.Dhr shows no anomalies or deviations that would have affected the surgical outcome or contributed to the reported event.The device is used for treatment.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: TRABECULAR METAL SPINAL FUSION DEVICE SIZE 14X14, ANGLED 6MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 10881674
• Report Number: 3005751028-2020-00098
• Device Sequence Number: 16820775
• Product Code: ODP
• UDI-Device Identifier: 00889024313286
• UDI-Public: (01)00889024313286
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K103033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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 Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 0610103061
• Device Lot Number: 63731469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 11/22/2020
• Supplement Report FDA Received Date: 02/09/2021
• 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