MAUDE Adverse Event Report: IMPLANTCAST GMBH ECOFIT® STEM IMPACTOR CROSS HOLE

Model Number 30390109

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2023

Event Type  malfunction  

Event Description

During an implantation on (b)(6) 2023, a deformation of the ecofit® stem impactor cross hole instrument (ref (b)(4)) occurred intraoperatively.The deformation on the instrument was detected by the surgical staff during surgery after implantation of the stem.A replacement instrument had to be obtained intraoperatively, it was available after 2min.Until a new instrument was available, for example, hemostasis and further preparations were taken care of.There were no adverse effects on the patient.The reporting person stated that it may be possible that the deformations occurred because the instrument may have been held at an angle during impaction.

Manufacturer Narrative

During an implantation on (b)(6) 2023, a deformation of the ecofit® stem impactor cross hole instrument (ref (b)(4)) occurred intraoperatively.The deformation on the instrument was detected by the surgical staff during surgery after implantation of the stem.A replacement instrument had to be obtained intraoperatively, it was available after 2min.Until a new instrument was available, for example, hemostasis and further preparations were taken care of.There were no adverse effects on the patient.The reporting person stated that it may be possible that the deformations occurred because the instrument may have been held at an angle during impaction.The ecofit® stem impactor cross hole ref (b)(4) was availble for analysis.The optical examination of the ecofit® stem impactor shows that the peg as well as the contact surface surrounding it are deformed and show strong traces of hammering.The edges of the contact surface are deformed to such an extent that positioning is no longer possible.The peg is so badly deformed that it can no longer be inserted into the hole on the stem.The composition of the material used for impact instrumente are deliberately chosen to be softer than the material used for implants.It is therefore possible that deformations may occur as a result of multiple impacts.However, it is unlikely that the damage to the impactor visible in this case occurred during the use prescribed in the surgical technique.The reporting person indicated that the instrument may have been held at an angle during use.It is clear from the surgical technique that the instrument must be held vertically during use.It is conceivable that access to the stem was difficult for surgical or patient-related reasons and therefore procedure deviated from the surgical technique.The damages resulted from a combination of expectable signs of wear due to intended use and unintentional incorrect use.There was a risk that the surgery could no longer be continued properly.Consequently, the instrument was removed by the surgical staff and a replacement instrument was brought in.After a review of the product and manufacturing documentation, a technical cause that could be traced back to manufacturing problems can be ruled out.The standard surgical techniques have been checked in terms of content, no errors could be found.This incident was assigned to the error pattern "deformation of the instrument" with the consequence " extension of the operating time ".For the marketing period (b)(6) 2020 to (b)(6) 2022, no further incidents have become known regarding the error pattern.The calculated occurrence rate is 0,001%.This value is below the limit value of 1% defined in the risk analysis.

• Brand Name: ECOFIT® STEM IMPACTOR CROSS HOLE
• Type of Device: IMPACTOR
• Manufacturer (Section D): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, lower saxony 21614 ; GM 21614
• Manufacturer (Section G): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, lower saxony 21614 ; GM 21614
• Manufacturer Contact: frank ansorge ; lueneburger schanze 26; buxtehude, lower saxony 21614 ; GM 21614
• MDR Report Key: 17928870
• MDR Text Key: 325582109
• Report Number: 3012523063-2023-00011
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2023

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 Model Number: 30390109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1