MAUDE Adverse Event Report: ZIMMER GMBH IMPACTOR 36

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturer received document for review.The manufacturer did not receive the device for investigation.Where lot number was received for the device, the device history records were reviewed and found to be conforming.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

During surgery the allofit impactor was defective.The instrument has been used approx.50 times.

Manufacturer Narrative

Investigation results were made available.Dhr-review: ref: 01.00209.114; lot: 4502311529.Yield: 36.Delivered: 36.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: fracture.Event description: it was reported that during an initial surgery the allofit impactor 36 was fractured.To complete the procedure another instrument was used.A surgical delay of 5 min.Occurred.The instrument has been used approx.50 times and the surgical technique was followed.Review of received data: neither medical nor patient data provided.Devices analysis: visual examination: the broken impactor was returned for investigation.The breakage occurred at the thread of the instrument.More specifically, the fracture runs through the size and reference marking of the instrument.On the outer surface normal signs of usage are found.The thread shows extensive deformation.Based on this visual examination the complaint can be confirmed.Review of product documentation: the compatibility check could not be performed as only one product had been reported.Inspection plan.Characteristic ¿dimension (13 +1/0) with scope of testing: 10%.Means of inspection: caliper.Characteristic feature ¿thread (m10) with scope of testing: 100%.Means of inspection: thread gauge.Root cause analysis: root cause determination using rmw: instrument breaks, deforms, diverges impairing its function due to inadequate design for intended performance.Not possible, as 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, as according to material compatibility specification, the material has been tested.Further, 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 the device was used approx.50 times.Fracture of instrument due to general corrosion (crevice, pitting, galvanic).Not possible, as no signs of corrosion were identified during investigation.Instrument breaks, deforms, diverges impairing its function due to excessive deterioration of instrument during long term use.Possible, as the device was used approx.50 times.Damaged instruments, implants, body or wrong operational step due to surgeon or staff unfamiliar with instrument usage and handling.Possible, as no information about the surgery was provided.Instrument breaks, deforms due to off-label/ abnormal-use.Possible, as no information about the surgery was provided.Instrument cannot be used with the mating instrument or mating implant as intended (due to damaged and/ or seized instrument) due to failure of instrument assembly condition due to off-label/ abnormal-use, excessive deterioration.Possible, as the fracture line runs through the thread of the instrument, it can no longer be used with the mating instrument.Conclusion summary: the broken impactor has been returned for an investigation.Based on the visual examination the complaint could be confirmed.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.However, it is possible that too high forces or forces applied at an angle may led to the fracture of the device.Nevertheless, based on the available information no unique root cause could be determined.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).

Event Description

Investigation results are now available.

• Brand Name: IMPACTOR 36
• Type of Device: IMPACTOR
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8178496
• MDR Text Key: 131141014
• Report Number: 0009613350-2018-01256
• Device Sequence Number: 1
• Product Code: HWA
• 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: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• 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: 4502311529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1