MAUDE Adverse Event Report: ZIMMER GMBH IMPACTOR, 32

Model Number N/A

Device Problem Break (1069)

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

Event Date 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

The product was received for investigation and the investigation has been initiated.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Additional information was requested to the appropriate representatives.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is cmp-(b)(4).Investigation initiated.

Event Description

During the surgery on (b)(6) 2017, the impactor got broken.Surgery was completed with another device.Note: 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

No trend considering the following event is identified: fractured impactor.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event summary: it was reported that the impactor has broken.No medical data such as surgical notes or any other case-relevant documents received.Visual examination: the broken impactor was returned for an investigation.The breakage occurred at the threads of the instrument.Moreover, there are some signs of usage visible.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 assessment.- 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 assessment.- instrument breaks due to degradation of material due to cleaning and sterilization => possible, as it cannot be excluded based on the available information.It remains unknown, how often the impactor has been sterilized.- damaged instruments, implants, body or wrong operational step due to surgeon or 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 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 => possible, as it cannot be excluded based on the available information.Extraordinary high forces might have been applied during surgery.Conclusion summary the broken impactor was returned for an investigation.It might be a possibility that unusual high impact / torque forces might have occurred on the instrument during surgery, leading to the breakage.Another possibility is that the setting instrument was screwed on incompletely or at an angle, which could lead to high stress in the material during impaction.However, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: IMPACTOR, 32
• Type of Device: IMPACTOR, 32
• 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: 6604129
• MDR Text Key: 76526935
• Report Number: 0009613350-2017-00759
• Device Sequence Number: 1
• Product Code: HSZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• 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: 840.6024
• Device Lot Number: 16.302433
• Other Device ID Number: 00889024383289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2016
• 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