MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 PRECUT CURVED RODS, TI ALLOY 55MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	07.02015.008
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.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.Reference report 3012447612-2019-00548.
Event or Problem Description
It was reported that a hospital received the incorrect product in two packages.The packages contained 50mm rods instead of the labeled 55mm rods.The product was discovered by the hospital complainant and there was no reported patient involvement.This is report one of two.
Additional Manufacturer Narrative
Additional information in b4, d10, g4, g7, h2, h3, h6: methods, results, and conclusion codes.The returned device was evaluated.Visual inspection confirmed that the physical etch on the product is 50mm.However, the product label states that the product is 55mm.The product was measured and found to be 55mm.Therefore, the products are incorrectly etched.The complaint is confirmed for etching issue.A review of the manufacturing records did not identify any issues or nonconformances related to the reported event.However, the complaint confirmed that the product left non-conforming with the incorrect etch.A supplier corrective action was previously initiated and found that the description at the supplier was incorrectly changed in the system during a name conversion.
Event or Problem Description
It was reported that a hospital received the incorrect product in two packages.The packages contained 50mm rods instead of the labeled 55mm rods.The product was discovered by the hospital complainant and there was no reported patient involvement.This is report one of two.

• Brand Name: 5.5 PRECUT CURVED RODS, TI ALLOY 55MM
• Common Device Name: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9501511
• Report Number: 3012447612-2019-00547
• Device Sequence Number: 1304475
• Product Code: NKB
• UDI-Device Identifier: 00889024003965
• UDI-Public: (01)00889024003965(10)P142565
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K150896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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: Other
• Device Catalogue Number: 07.02015.008
• Device Lot Number: P142565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1