MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DYNESYS REPLACEMENT BLADE FOR SPACER CUTTER

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer did receive per for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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 cmp-(b)(4).

Event Description

The dynesys blade has been worn out during the surgery, so there was a surgical delay of 40 min and the surgery was performed using a scalpel.

Manufacturer Narrative

Investigation results were made available.Review of event description: it was reported that the dynesys blade has been worn out.There was a surgical delay of 40 min and surgery was performed using a scalpel.The event happened on (b)(6) 2020.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.Conclusion: it was reported that the dynesys blade has been worn out.There was a surgical delay of 40 min and surgery was performed using a scalpel.The event happened on (b)(6) 2020.No product was returned, hence visual and dimensional evaluation could not be performed; therefore, the condition of the part is unknown.No pictures of the device were received.The lot number of the device is also not available to check the manufacturing records and material certification.Based on the investigation the reported event cannot be confirmed.The investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

No event update.Investigation results are now available.

• Brand Name: DYNESYS REPLACEMENT BLADE FOR SPACER CUTTER
• Type of Device: DYNESYS REPLACEMENT BLADE FOR SPACER CUTTER
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10458852
• MDR Text Key: 204517413
• Report Number: 0009613350-2020-00391
• Device Sequence Number: 1
• Product Code: HXZ
• 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: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.03799.022
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 36 YR