MAUDE Adverse Event Report: AESCULAP AG ELAN 4 1-RING DIAMOND BURR X-COARSE D6.0; HIGH SPEED POWER SYSTEMS

Model Number GP176R

Device Problem Component Missing (2306)

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

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: there are several areas with missing diamonds are visible.A safety team was convened.It was discovered that the failure was caused by a change of the manufacturing process.Since this change, the burrs were no longer brushed after the coating to remove the loose diamonds.Due to this reason, the risk occur that the diamonds can detach off the burr.A patient hazard cannot be assessed at this stage, thus the following task were initiated: creation of a health risk assessment; statement of the manufacturer; blocking of the warehouse; clinical evaluation; forward a list of requirements to manufacturer; detection of remaining nickel on loosened diamond; follow-up safety team.Based on the above activities if additional information is obtained, an additional follow up med watch will be submitted.Based on the information available as well as a result of the investigation, the root cause of the failure is most probably a manufacturing error.

Event Description

Country of complaint: (b)(6).It was reported that there were five complaints about lost diamonds from diamond burrs while milling in bone.Surgery delay longer than 15 minutes was reported.No harm to the patient was reported.All med watches submissions related to this report are: 9610612-2017-00077, 9610612-2017-00078, 9610612-2017-00079, 9610612-2017-00080, 9610612-2017-00081.

• Brand Name: ELAN 4 1-RING DIAMOND BURR X-COARSE D6.0
• Type of Device: HIGH SPEED POWER SYSTEMS
• 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: 6387228
• MDR Text Key: 69379824
• Report Number: 9610612-2017-00078
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Type of Report: Initial
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GP176R
• Device Catalogue Number: GP176R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Distributor Facility Aware Date: 02/10/2017
• Device Age: 14 MO
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other