MAUDE Adverse Event Report: INNOMED, INC. INTERCHANGEABLE HEAD-50 MM- DELRIN; EXTRACTOR

Model Number 5202-50

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 06/28/2017

Event Type  Injury  

Event Description

The following description was received by the cdrh on 6/30/2017 with assigned mdr report key (b)(4): a 50mm radiotransparent trial femoral head broke upon insertion in the left hip.Response: the report was received by the importer on (b)(6) 17.The initial reporter was contacted via phone on the same date, and a request was made to forward pictures of the device because based on the description in the report, it was not understood how the device was determined to be an innomed part.Pictures of the device was received at innomed on (b)(6) 2017, and after review, it was verified as an innomed part.The importer also requested more information via email regarding the series of events that led to the break as the above description is not sufficient enough to perform a thorough investigation.A follow up email was sent on (b)(6) 2017 requesting the same information.No response was received from the initial reporter.When the requested information is provided, an investigation will ensue, and an update will be forwarded to the cdrh.

• Brand Name: INTERCHANGEABLE HEAD-50 MM- DELRIN
• Type of Device: EXTRACTOR
• Manufacturer (Section D): INNOMED, INC.; 103 estus drive; savannah GA 31404
• MDR Report Key: 6785866
• MDR Text Key: 82465993
• Report Number: 1833053-2017-00003
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 00840277104496
• UDI-Public: 00840277104496
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/10/2017,08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 5202-50
• Device Catalogue Number: 5202-50
• Device Lot Number: 0114I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/14/2017
• Device Age: 42 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1