MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC HUDSON DRILLING ATTACHMENT F/BPL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 530.792

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.The device was evaluated and the reported condition was confirmed.A visual and functional assessment was performed which found that the unit failed the untrue running check-wobbling/ inconsistent rotation movement.During repair, it was determined that there was an unknown liquid on the pinion cage and the transmission shaft was broken.It was further observed that there was an unknown debris on the ball bearings.The assignable root causes were determined to be due to improper cleaning and normal wear.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that the hudson drilling attachment device had an undetermined malfunction.During in-house engineering evaluation, it was observed that the transmission shaft was broken and there were unknown debris on the ball bearings.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report 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.Device evaluation update: upon further investigation, it was determined that an unusual noise was noticed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: HUDSON DRILLING ATTACHMENT F/BPL
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7637090
• MDR Text Key: 112550692
• Report Number: 8030965-2018-54584
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10886982240279
• UDI-Public: (01)10886982240279(11)170505
• 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
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.792
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1