MAUDE Adverse Event Report: ZIMMER GMBH DYNESYS, HA PEDICLE SCREW + SET SCREW, 6.0X40; N/A

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/29/2019

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The manufacturer did not receive x-rays, or other source documents for review.The lot number of the device was received.The device history records will be reviewed during investigation.An e-mail requesting additional information was sent to the appropriate representatives.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that during surgery the dynesys pedicile screw failed.No other information is available at the moment.Additional information has to be requested.

Event Description

Please refer to report 0009613350-2019-00672.

Manufacturer Narrative

Harm: s1 - no patient, user, or other stakeholder harm (assumed).Hazard: unknown event.No event description or relevant medical data has been received.Product has not been returned.The product is intended for treatment.The investigation results did not identify a non-conformance or a complaint out of box (coob).Based on the significant lack of information, no failure mode could be identified and no root cause could be found.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: DYNESYS, HA PEDICLE SCREW + SET SCREW, 6.0X40
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9304446
• MDR Text Key: 196480819
• Report Number: 0009613350-2019-00672
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.03746.040
• Device Lot Number: 2943463
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other