MAUDE Adverse Event Report: INNOMED INC. NAMBA HIP SLIDE; RETRACTOR

Model Number	6890
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The following description was received by the cdrh on 02/17/2016, (b)(4).Immediately following a right total hip arthroplasty, post-operative radiography viewed by the surgeon was noted to be abnormal.The patient was returned back to surgery and the surgeon explored the sight finding a foreign object within the hip.The foreign object was a corner of the namba hip slide that had broken off.Approximate length- 3.5 cm.Approximate depth- 1.0 cm.Did require replacement of new hardware.Response: the report was received on 2/22/2016.The initial reporter was contacted and a request was made to have the device returned for an evaluation.The initial reporter relayed that the device could not be returned for evaluation purposes.It was then asked of the initial reporter if pictures of the broken item could be forwarded in lieu of the physical item.The initial reporter responded that the pictures would be forwarded.A follow up email was sent to the initial reporter on 2/29/2016.It was again requested to forward photographs of the broken item, and it was also explained that it would be difficult to perform a suitable evaluation without evidence.On 3/8/2016, the initial reporter was contacted for the third time, and once again a request was made to have photographs of the broken item forwarded.The initial reporter replied that they would be forwarded on 3/9/2016 or 3/11/2016.The photographs were not forwarded.At this time, innomed is unable to carry out an evaluation.Follow up activities will be performed, and an update submitted when evidence of the break is forwarded, and an evaluation ensues.

• Brand Name: NAMBA HIP SLIDE
• Common Device Name: RETRACTOR
• Manufacturer (Section D): INNOMED INC.; 103 estus drive; savannah GA 31404
• MDR Report Key: 5539717
• Report Number: 1833053-2016-00001
• Device Sequence Number: 13528149
• Product Code: GAD
• UDI-Device Identifier: 00840277103925
• UDI-Public: 00840277103925
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/10/2016
• Report Date (Section F): 03/31/2016

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
• Operator of Device: Physician
• Device Model Number: 6890
• Device Catalogue Number: 6890
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67.0 YR
• Date Report Sent to FDA: 03/31/2016