MAUDE Adverse Event Report: AESCULAP AG MIOS REAMER SHANK HARRIS; HIP ENDOPROSTHETICS

Model Number NF936R

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation conclusion: investigation performed by great batch medical - complaint sample, offset reamer handle, was evaluated and the reported event was confirmed.The dhr was not reviewed as the product was manufactured in july 2005.Manual surgical instruments have a limited life-span which is generally determined by wear or damage due to repeated intended use.Trend analysis was performed from december 2012 to december 2013 and no similar events have been reported.No further investigation is required; greatbatch medical will continue to monitor for trends.

Event Description

It was reported that there was an intraoperative issue with the mios reamer shank.On the instrument back table, during removal of the milling tool shaft from the set, the metal pin fell out.After discovery of the defect, the straight milling tool shaft was used instead.The procedure was completed without incident.There was no delay in the operation or harm to the patient.Additional information is not available.

• Brand Name: MIOS REAMER SHANK HARRIS
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 8340174
• MDR Text Key: 136285185
• Report Number: 9610612-2019-00046
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NF936R
• Device Catalogue Number: NF936R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/26/2013
• Date Manufacturer Received: 11/14/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1