MAUDE Adverse Event Report: GREATBATCH MEDICAL EZ CLEAN REAMER HANDLE

Model Number 00-1206-090-10

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

Integer was originally aware of the complaint event on 05-feb-2018 but at the time the event was deemed not reportable based on the information provided.However, upon receipt and inspection of the complaint sample, it was discovered that the power adaptor was slightly bent and therefore became reportable based on previously reported complaints.From inspection, it was observed there was material deformation on the power adaptor that may have been caused by using an incompatible power tool (not supplied by integer).A manufacturing review did not reveal any discrepancies.The observed bent power adaptor and deformation are not consistent with intended use.Thus, the event is attributed to user error caused or contributed to event.No further investigation is required.Report source is distributor, (b)(4).

Event Description

It was reported during a primary hip procedure that the instrument was sticking and it was hard to place a reamer on them correctly.The procedure was completed with another instrument and there were no adverse events reported as a result of the malfunction.

• Brand Name: EZ CLEAN REAMER HANDLE
• Type of Device: REAMER HANDLE
• Manufacturer (Section D): GREATBATCH MEDICAL; 4545 kroemer road; fort wayne IN 46818
• Manufacturer (Section G): GREATBATCH MEDICAL; 4545 kroemer road; fort wayne IN 46818
• Manufacturer Contact: tony singh ; 4545 kroemer road; fort wayne, IN 46818 ; 2607557466
• MDR Report Key: 7477563
• MDR Text Key: 107709802
• Report Number: 3004976965-2018-00028
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2018

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 Operator: Health Professional
• Device Model Number: 00-1206-090-10
• Device Catalogue Number: T2756
• Device Lot Number: 56596348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2015
• 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