MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BATTERY REAMER/DRILL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.605

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The manufacturing location was unknown.The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the battery reamer device was noisy and made a crunching sound.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.There was patient involvement.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The manufacturer location was documented as unknown in the initial report.The location has been updated to obedorf.Contact office name/address has been updated accordingly to reflect the correct manufacturing facility.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Concomitant medical products: the date returned for evaluation was reported as 12/6/2019 on the initial report.The correct date is 12/16/2019.Investigation summary: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reamer showed signs of immersion as it failed check the cannulation assessment.It was determined that there was noticeable and excessive grinding noise observed during the assessment.It was determined that there was an unknown liquid found on the sub assembly components.It was determined that there were excessive debris found on the internal components.It was determined that the ball bearings were corroded.Therefore, the reported condition was confirmed.The assignable root cause was traced to improper maintenance.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: BATTERY REAMER/DRILL
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9457987
• MDR Text Key: 196090026
• Report Number: 8030965-2019-71038
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819137103
• UDI-Public: 7611819137103
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 530.605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 12/24/2019; 12/24/2019
• Supplement Dates FDA Received: 12/31/2019; 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1