MAUDE Adverse Event Report: AESCULAP AG ACCULAN NIMH BATTERY; LARGE BONE POWER SYSTEMS

Model Number GA676

Device Problem Explosion (4006)

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

Event Date 12/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported there was an issue with a battery.While the product was stored on a shelf, it "exploded".The device was not in use at the time.Further information has been requested.

• Brand Name: ACCULAN NIMH BATTERY
• Type of Device: LARGE BONE 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: 8511632
• MDR Text Key: 142206695
• Report Number: 9610612-2019-00266
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA676
• Device Catalogue Number: GA676
• Device Lot Number: 51774997
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/08/2019
• Device Age: 88 MO
• Date Manufacturer Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2011
• 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