MAUDE Adverse Event Report: ZIMMER GMBH IMPACTOR, 36; N/A

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: item: impactor, 36 catalog #: 01.00209.114, lot #: 4501852854.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.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.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 - 00444.The actual device reported is not marketed in usa, but devices with similar characteristics (i.E 01.00109.808 impactor) are marketed in usa, and therefore this report was filed.

Event Description

It was reported that during surgery an impactor, 36 had broken.It was also reported that the surgery was completed with another set of instruments and the surgery was delayed by 3 min.Notes: 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

Investigation results were made available.Additional: h2, h6.Correction: b4, d10, g4, g7, h3, h10.Trend analysis: a trend considering the following event is identified: impactor fractured two additional similar investigated events for the lot number 4501773001 has been found (b)(4).Based on the available information further investigation has been initiated to determine the necessity of potential corrective and/or preventive actions.Within the issue evaluation it was determined that the design is deemed acceptable and the instrument fracture risk is acceptable and covered by the risk management file.Therefore it had been decided, that it was not necessary to proceed new actions for this issue.Dhr-review: ref#: 01.00209.114 lot#: 4501773001.- yield: 44.- delivered: 44.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Ref#: 01.00209.114 lot#: 4501852854.- yield: 44.- delivered: 44.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event description: it was reported that the impactors broke during surgery.Review of received data: no medical data such as surgical notes or any other case-relevant documents received devices analysis: - visual examination: three broken impactors have been returned for an investigation.The breakages occurred at the threads of the instruments.No other conspicuousness found.Root cause analysis: root cause determination using rmw: - instrument breaks, deforms, diverges impairing its function due to inadequate design for intended performance.=> not possible -> a systematic issue with design would have been detected as part of the issue evaluation.- instrument breaks, deforms, diverges impairing its function due to mechanical properties of material insufficient.=> not possible -> a systematic issue with material properties would have been detected as part of the issue evaluation.- instrument breaks due to degradation of material due to cleaning and sterilization.=> possible, as it cannot be excluded based on the available information.- damaged instruments, implants, body or wrong operational step due to surgeon or staff unfamiliar with instrument usage and handling.=> possible, as it cannot be excluded based on the available information.A deterioration in function as a result of repeated use is possible.- damaged instruments, implants, body or wrong operational step due to surgeon or staff unfamiliar with instrument usage and handling.=> possible, as it cannot be excluded based on the available information.Extraordinary high forces might have been applied during surgery.- instrument breaks or deforms due to off-label / abnormal-use.=> not possible.Instrument does not show any signs of an off-label use.Conclusion summary: three broken impactors have been returned for an investigation.It might be a possibility that unusual high impact / torque forces might have occured on the instrument during surgery, leading to the breakage.Another possibility is that the setting instrument was screwed on incompletely or at an angle, resulting in high stress in the material, which could have led to the breakage.Further investigations have been performed in 2015 for a similar issue and has identified "usage/men (incorrect use and off label use)" as the root cause.An evaluation of this issue has been initiated in december 2017 and it was determined that the design is acceptable.The performed risk score assessment showed a ¿moderate-medium¿ risk.The worst case impact with regards to patient risk was an extended surgery of less than 15 minutes.Therefore it had been decided, that it was not necessary to proceed new actions for this issue.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).The following reports are associated with this event: (b)(4).

• Brand Name: IMPACTOR, 36
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7436156
• MDR Text Key: 105891220
• Report Number: 0009613350-2018-00443
• Device Sequence Number: 1
• Product Code: HSZ
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• 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: 01.00209.114
• Device Lot Number: 4501773001
• Other Device ID Number: 00889024385573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1