MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SETTING INSTRUMENT FOR POLE PLUG; N/A

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 01/24/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for 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.(b)(4).

Event Description

It was reported that during surgery while screwing in the pole locking screw, the snap ring, which holds the screw on the setting instrument, loosen itself.Post surgery it was noticed in the x-ray that the snap ring remained in the surgical site.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the clamp ring loosened intraoperatively from the setting instrument for pole plug.Post surgery it was noticed in the x-ray that the snap ring remained in the surgical site.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: visual examination: the setting instrument has been returned for an investigation.The tip of the instrument has fractured off.Additionally, there are some signs of usage at the metal part of the instrument.The shoulders at the tip of the instrument are deformed.See pictures attached.Review of product documentation: device purpose: this device is intended for treatment.Conclusion: it was reported that the clamp ring loosened intraoperatively from the setting instrument for pole plug.Post surgery it was noticed in the x-ray that the snap ring remained in the surgical site.Based on the investigation the reported event can be confirmed.As part of the instrument remained in the patient¿s body, it is recommended to monitor the patient.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).The most likely root cause leading to the fracture of the instrument might be related to instrument design and / or conditions of use.A deep investigation was performed including the initiation of corrective and preventive actions and health hazard evaluation to assess the necessity of corrective actions and/or a field action.The capa investigation concluded the below root causes: surgeon has limited visibility of the plug during insertion with the straight setting device of revision d.The surgeon may not see when the pole plug is fully seated (leading to a potential deformation of the instrument tip).The described surgical technique is not always followed and the instrument has been misused.Both surgical techniques of the alloclassic cup and alloclassic it cup do describe the correct handling of the pole plug inserter.However, the descriptions of how to use the setting instrument are not fully aligned.A cad analysis showed that a potential minimal collision between the instrument and the acetabular cup may happen during the insertion of the pole plug.This collision may result in the instrument slightly separating from the pole plug, which may lead to a deformation of the setting instrument.Corrective actions related to the affected setting instrument have been implemented.These corrective actions include the following: the design of the instrument was improved and design revision e has been released on sept 22, 2020.The visibility of the surgical field was improved by flattening the tip of the straight setting instrument and the potential worst case collision/overlap between instrument and acetabular cup was eliminated.A surgical technique amendment was implemented.The descriptions of the alloclassic cup surgical technique was aligned with the description in the surgical technique of the alloclassic it cup.Alloclassic cup was released and is valid since sept 22, 2020.Evaluation and associated risk assessment showed that the probability of occurrence of harm is still within the given limits of the corresponding risk management file, and therefore is considered low risk.Based on this, zimmer biomet decided to not initiate an fsca for this product.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: SETTING INSTRUMENT FOR POLE PLUG
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9710481
• MDR Text Key: 179411804
• Report Number: 0009613350-2020-00065
• Device Sequence Number: 1
• Product Code: HWC
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• 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: 01.00009.001
• Device Lot Number: 4502311556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR