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

Model Number N/A

Device Problem Sticking (1597)

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

Event Date 12/27/2016

Event Type  malfunction  

Manufacturer Narrative

During complaint investigation it came aware that also the wagner cone prosthesis®, screw for trial stem caused the reported event, thereof this mdr was additionally added to the mdr for the screw driver.As for zimmer specialists to perform an in-depth analysis it is required to have all necessary information at hand, it was therefor tried several times to receive more information for this case.Additional information as follows was requested at complainant the latest one on (b)(6) 2017.Lot number of the device.Patient information: dob, weight, etc.Trend analysis: no trend identified.As no lot numbers were provided for the devices, the device history records could not be reviewed.An e-mail requesting missing device data information was sent on month day, year.At zimmer (b)(4) all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer (b)(4) and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Event summary: it was reported that during hip arthroplasty the screw driver got stuck in the screw of the trial stem.When removing it with a lot of force, the metal ring of the tip broke off.Review of received data: no medical data such as surgical notes or any other case-relevant documents received.Devices analysis: visual examination: only the broken off ring from the tip of the screw driver was returned for an investigation.This ring did not show any further conspicuousness.Review of product documentation: the surgical technique for the wagner cone primary was reviewed.The screw driver (ref (b)(4)) is used to tighten the wagner cone screw (ref (b)(4)) in order to assemble the trial stem (proximal and distal part).This is recommended to be done outside of the body.Root cause analysis: wagner cone screw ref (b)(4): root cause determination rmw: line r-3.1.2: instrument cannot be used with the mating instrument or mating implant as intended due to failure of instrument mating condition => possible, as screw driver broke when using it with the screw.Conclusion summary: no exact root cause could be determined, as neither the screw driver nor the wagner cone screw were available for an investigation.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

Event Description

It was reported that the nurse used the screwdriver with self-holding hexagon, l, 3.5 mm, 245 mm to put together the wagner cone prosthesis ® trial and the neck.When she should remove the screwdriver it was stuck into the trial.The surgeon help her and finally the screw driver came loose.It was then notices that the small metal ring was loose and it was at the tip of the screw driver.Surgery was delayed for 20 minutes.

• Brand Name: WAGNER CONE PROSTHESIS®, SCREW FOR TRIAL STEM
• Type of Device: NA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6581374
• MDR Text Key: 75624475
• Report Number: 0009613350-2017-00667
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• 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: UNKNOWN
• Other Device ID Number: 00889024282339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1