MAUDE Adverse Event Report: ZIMMER GMBH DYNESYS TORSION TORQUE DRIVER; N/A

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The manufacturer received images and other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.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.(b)(4).

Event Description

It was reported that during a surgery the torsion torque driver has seriously fractured (thoroughly) when fastened with the blocker.Surgery completed as planned using a new one torsion torque driver.

Manufacturer Narrative

Additional: a5, d4, d10, h2, h6.Correction: b4, e4, g4, g7, h3, h10.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.No trend considering the following event is identified: instrument breakage.Event summary: it was reported that the dynesys torsion torque driver has seriously fractured when fastened with the blocker.This occured during surgery.Another torque driver with the same ref.Number was used.Review of received data: 3 pictures were received.All pictures show the fractured instrument.Devices analysis, visual examination: the returned instrument is broken into two pieces.The whole hex tip came apart.No further deformation can be seen on the instrument.The blue handle does not show any damages.Based on this visual examination the reported event can be confirmed.See pictures attached.Review of product documentation: the ifu outlines inspection and functional testing instructions for the end user and details specific steps to take if the instrument appears to be damaged or does not function as intended.- according to the cer the torsion torque driver is an alternative to the hexagonal screw driver.The torsion torque driver is inserted into the counter torque handle and is designed to tighten the set screws to a torque of 4 nm.Conclusion summary: it was reported that the instrument was broken during the surgery.In the complaint it is mentioned that the instrument was used between 50 and 60 times.As no surgical reports have been received, it cannot not be said how the instrument was used.It is not known if the instructions given in the surgical technique and ifu were followed for a correct instrument usage.It can be suspected that the instrument has been used intensely and exceeded the useful life.However, based on the available information, an exact root cause for the instrument breakage could not be determined.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).

Event Description

No change to previously reported event.

• Brand Name: DYNESYS TORSION TORQUE DRIVER
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7812048
• MDR Text Key: 118404262
• Report Number: 0009613350-2018-00849
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 03/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.03799.040
• Device Lot Number: 15138229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 08/24/2018
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 03/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1