MAUDE Adverse Event Report: ZIMMER SURGICAL SA AO REAMER ATTACHMENT 350 RPM

Catalog Number 89-8509-435-10

Device Problems Blocked Connection (2888); Protective Measures Problem (3015); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 07/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to the manufacturer at the date of this report.A follow-up medwatch will be submitted once the investigation is completed or if any additional information is received.

Event Description

It was reported that the ao reamer attachment 350 rpm, part number 89-8509-435-10, serial number (b)(4) was blocked and not functional.During the partial hip replacement surgery, a delay of 50 minutes was reported.The patient was under anesthesia.The reason for the delay was due to time needed for the diagnosis of the handpiece and search of the replacement.Another device was used to complete the surgery.There was no additional harm or injury to the patient reported.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Universal ao reamer attachment 350 rpm, part number 89-8509-435-10, serial number (b)(6) was not returned for complaint investigation.Therefore, the device could not be visually inspected in an effort to confirm the defect.Device history record review was performed and no issue was discovered during the manufacturing process that could explain the defect reported.A follow-up medwatch will be submitted if the product is returned or if additional information is received.

Event Description

It was reported that the universal ao reamer attachment 350 rpm, part number 89-8509-435-10, serial number (b)(6) was blocked and not functional.During the partial hip replacement surgery, a delay of 50 minutes was reported.The patient was under anesthesia.The reason for the delay was due to time needed for the diagnosis of the device and search of the replacement.Another device was used to complete the surgery.There was no additional harm or injury to the patient reported.

• Brand Name: AO REAMER ATTACHMENT 350 RPM
• Type of Device: AO REAMER ATTACHMENT 350 RPM
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3 chemin du pre fleuri; plan-les-ouates; geneva 1228 ; SZ 1228
• MDR Report Key: 8234632
• MDR Text Key: 132764966
• Report Number: 0008031000-2019-00003
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-8509-435-10
• Device Lot Number: 5009614
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 79