MAUDE Adverse Event Report: ZIMMER GMBH WAGNER CONE PROSTHESIS, SCREW FOR TRIAL STEM; WAGNER CONE PROSTHESIS SYSTEM

Model Number N/A

Device Problem Sticking (1597)

Patient Problem No Information (3190)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: item: screwdriver with selfholding hexagon, l, 3.5 mm, 245 mm, catalog #: 109.02.030, lot #: 4502034426.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The manufacturer did not receive x-rays, or other source documents for review.The device history records were reviewed and found to be conforming.An e-mail requesting the following additional information was sent on june 13, 2018 to the appropriate representatives: surgical reports, other reports (stickers).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).The following reports are associated with this event: 0009613350-2018-00667.

Event Description

It was reported that during a surgery the nurse noticed that the screwdriver (screwdriver with self-holding hexagon, l, 3.5 mm, 245 mm) did stick into the head screw (wagner cone prosthesis, screw for trial stem) and could not been separate.It was also reported that there was no harm or injury to patient.The implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.

Manufacturer Narrative

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: jamming.Event summary: it was reported that the screwdriver and the wagner trial screw jammed.There was no surgery delay.The trials were finished at the moment of the event.No consequence on the patient body/health.There is no other contributing event.Patient information are not provided due to privacy policy.The screwdrive was brand new.Review of received data: no medical data such as surgical notes or case-relevant documents have been received.Patient information is not provided due to privacy policy.Devices analysis - visual examination: the hexagonal screwdriver shows almost no signs of usage on all outer surfaces excluding the tip part.The screwdriver tip shows some scratches and deformed edges and is missing the spring ring at the tip.The received wagner screw to tighten the distal and the proximal wagner trial stems does not show any considerable deteriorations, deformations or imperfections on the outer surface.The visual examination of the inner surface shows that the wagner screw does not have a chamfer on the inner diameter of the hex socket, which was the specification according to drawing valid at the time of production.- measurements: to ensure the screwdriver has correct dimensions, relevant characteristics were measured with a caliper.- the diameter of the hexagonal tip can be confirmed.- the size of the screw tip can be confirmed.Further the dhr indicates that all components met all specifications.No measurements of the wagner screw were taken as the inner diameters of interest are not accessible and the missing chamfer is already recognizable by eye.Review of product documentation compatibility: the compatibility check was performed using the applicable surgical technique and showed that the product combination is approved by zimmer biomet.- inspection plan: - characteristic feature material snap ring 1.431 with scope of testing: 100%.Means of inspection: visual - characteristic feature functional test with scope of testing: 100%.Means of inspection: gauge root cause analysis root cause determination using rmw: - instrument breaks, deforms, diverges impairing its function.Due to inadequate design for intended performance => possible, as the drawing of the wagner screw, valid at the time of production, was missing an important chamfer of the inner hex socket.- instrument breaks, deforms, diverges impairing its function.Due to mechanical properties of material insufficient not possible -> as according to material compatibility specification the material has been tested.- instrument cannot be used with the mating instrument or mating implant as intended due to failure of instrument mating condition => possible, as the drawing of the wagner screw, valid at the time of production, was missing an important chamfer of the inner hex socket.As the reported failure was triggered by the old design of the wagner screw no risk assessment of the screwdriver was performed.Nevertheless, all risks and causes related to the screwdriver are listed in rmw.Conclusion summary based on the returned product and the given information the complaint, consisting of jamming, can be confirmed.The visual examination showed some deformation of the screwdriver tip and revealed that the screwdriver is missing the snap ring.Further, the visual examination showed that the wagner screw is missing the inner chamfer of the hex.Socket.The returned wagner screw was manufactured in 2010.At this time the wagner screw was manufactured according to drawing no.063.269.755 rev c.In this drawing revision c the inner section of the hex socket was missing an essential chamfer, which was introduced with drawing revision d on (b)(6) 2013.Due to the missing chamfer of the hex socket the snap ring of the screwdriver is blocked by the inner shoulder of the hex socket.Removal is only possible by destroying the snap ring of the screwdriver.Therefore, based on the given information and the results of the investigation, we could recreate the reported issue.The reported issue was corrected by an update of drawing no.063.269.755 rev.C to rev.D on (b)(6) 2013.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: WAGNER CONE PROSTHESIS, SCREW FOR TRIAL STEM
• Type of Device: WAGNER CONE PROSTHESIS SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7649855
• MDR Text Key: 112891841
• Report Number: 0009613350-2018-00666
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK113556
• 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: 11/28/2018

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.00569.001
• Device Lot Number: 10595631
• Other Device ID Number: 00889024282339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 11/27/2018
• Supplement Dates FDA Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other