MAUDE Adverse Event Report: ZIMMER GMBH IMPACTOR, HOODED, 32; N/A

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 09/24/2019

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.The lot number of the device was received.The device history records will be reviewed during investigation.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 the impactor was broken while impacting the liner in the cup.Another impactor was used to complete the procedure.30 min delay was reported to remove the liner and the broken part of the instrument out of the patient.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.D11 - medical products and therapy date.Detail of product: item number 0100013508, item name durasul, alpha insert, hooded, hh/32, lot # unknown.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: a trigger considering the following event is identified: device fracture.9 similar investigated events within last 6 months for item number 840.6033 have been found.Event description: it was reported that the hooded impactor 32 broke during surgery.Review of received data: no medical data such as surgical notes or any other case-relevant documents received, due to patient privacy policy.Device analysis: visual examination: the fractured impactor 32 hooded was received for investigation.The fracture runs through the first thread turn.On the hemispherical surface one distinct scratch can be seen.Review of product documentation: this device is intended for treatment.Compatibility: compatibility check showed that the compatibility between the hooded impactor 32 and the reported durasul alpha insert hh/32 (ref: 01.00013.508) was approved by zimmer biomet.Due to missing device identification of the impactor handle the compatibility between handle and the hooded impactor 32 is unknown.Conclusion: it was reported that the hooded impactor 32 broke during surgery.The visual examination confirmed the fracture which runs through the thread.The investigation did not identify a non-conformance or a complaint out of box (coob).In conclusion, it is possible that the mating setting instrument was not screwed in completely, too high forces or forces applied at an angle led to the fracture of the device.Further, it is possible that the performance of the device was reduced due to repeated usage, cleaning and sterilization.Nevertheless, a specific root cause could not 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

Please refer to report 0009613350-2019-00602.

• Brand Name: IMPACTOR, HOODED, 32
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9196175
• MDR Text Key: 164833064
• Report Number: 0009613350-2019-00602
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• 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: 840.6033
• Device Lot Number: 4501445109
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention