MAUDE Adverse Event Report: AESCULAP AG ELAN 4 MIS SLEEVE F/1-RING HANDPIECES; HIGH SPEED POWER SYSTEMS

Model Number GB862P

Device Problem Component Missing (2306)

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

Event Date 09/29/2018

Event Type  Injury  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.Manufacturing site evaluation: evaluation on-going similar device elan 4 electric motor system: k152960 pending further information.

Event Description

It was reported by the healthcare professional to the company sales representative "during a spinal procedure, the complaint product gb862p was not secured enough and loosened when drilling.After the surgery, it was found that a spring inside the product was missing.The customer could not find it.Although checking the pictures of the procedure, the spring was not seen inside patient." absence of the spring was only noticed after the surgical procedure.Search was performed for the spring in the operation room after the surgical procedure.The customer was not sure when the spring was missing.An x-ray examination was performed, on (b)(6) 2018 to verify if the spring was retained in the patient.The x-ray showed no sign of the spring observed in the patient's body.No information about the patient is reported.The x-ray photo is not available.

Manufacturer Narrative

Post-operative medical intervention was necessary of an x-ray picture.The product is in good condition, but the spring is clearly missing inside the sleeve.After consulting r&d, it is possible that a wrong angle during positioning of the sleeve in combination with too high forces can damage the spring which could lead to a loosening.The failure is probably usage related, associated with a potential design lack.Handling failure led to the loosening of the spring.There is a possibility of the design lack which should be optimized.A product safety case has been requested.No capa will be necessary.

• Brand Name: ELAN 4 MIS SLEEVE F/1-RING HANDPIECES
• Type of Device: HIGH SPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8011404
• MDR Text Key: 125270960
• Report Number: 9610612-2018-00480
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• PMA/PMN Number: SEE H. 10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GB862P
• Device Catalogue Number: GB862P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Distributor Facility Aware Date: 11/12/2018
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention