MAUDE Adverse Event Report: ZIMMER CAS CAS FIXATION PIN 3.2D X 80MM STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source foreign: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0009617840-2021-00010, 0009617840-2021-00011, 0009617840-2021-00012, 0009617840-2021-00013, 0009617840-2021-00014, 0009617840-2021-00015, 0009617840-2021-00016, 0009617840-2021-00017, 0009617840-2021-00018, 0009617840-2021-00019, 0009617840-2021-00020.Customer 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.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 Description

It was reported the cas fixation pin primary packaging was not correctly sealed.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.Through evaluation of the pictures provided, and comparison with the packaging drawing for the subject product, the reported complaint is unconfirmed.Per the packaging drawing, the foil pouch is folded, not sealed, and does not provide any sterile barrier.There is no non-conformance per the images provided.

Event Description

No additional information on the reported event.

• Brand Name: CAS FIXATION PIN 3.2D X 80MM STERILE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer (Section G): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12300659
• MDR Text Key: 265803495
• Report Number: 0009617840-2021-00009
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K210121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20-8000-000-11
• Device Lot Number: 64808899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1