MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC DRILL/BURR ATTACHMENT FOR 2.35MM SHAFTS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number	05.001.123
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Burn(s) (1757); Unspecified Infection (1930); Pain (1994)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi: (b)(4).Concomitant med products and therapy dates: plug device, drill attachment j-latch coupling device, handpiece device, cable device, (b)(6) 2019.The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.Reference manufacturer report number: 8030965-2019-68139 for report 1 of 4, 8030965-2019-68161 for report 3 of 4 and 8030965-2019-68350 for report 4 of 4 of the same event.
Event or Problem Description
This is report 2 of 4 for the same event: it was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the ¿plug¿ was stuck in the handpiece device while being used together with the drill attachment j-latch coupling device, drill/burr attachment device, and cable device.According to the reporter, the issue was observed several times during pre-surgery.It was further reported that the patient had to be hospitalized longer due to a burnt lip (infection and pain) which resulted in swelling and post-surgical pain.There was a fifteen-minute delay to the surgical procedure.A spare device was available for use.There was patient involvement reported.There was medical intervention and prolonged hospitalization associated with this event.The exact date of the event was unknown.However, it was reported that the event occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional 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.Event: during a subsequent follow-up with the reporter, additional information was obtained.The reporter confirmed that there was no allegation of malfunction against the cable device (05.001.021).Therefore, the cable device (manufacturer report number: 8030965-2019-68350) has been excluded from this event.Furthermore, the event numbering represented in the initial report has been updated from ¿report 2 of 4 for the same event¿ to ¿report 2 of 3 for the same event¿.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional 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.Correction: device availability: d10: the device availability date was incorrect in the initial report.The date has been updated from 8/27/2019 to 9/6/2019.Service review: a review of the service history record indicates that the device has been serviced within the last year for a service condition that is not relevant to the current reported condition.Device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the device.During repair, it was determined that the device was absolutely jammed because the ball bearings were blocked.It was determined that the damage was caused due to insufficient lubrication and lack of maintenance at the customer site.It was further determined that the device was not properly reprocessed as recommended in the manufacturer¿s instruction for use (ifu).It was determined that the root cause of the issue was due to lack of oiling and lubrication, which created the heat development and finally blocking the attachment device.It was determined that the faulty attachment damaged the electric pen drive device.It was further observed that the bearing seized.It was further determined that the device failed pretest for check the tool coupling and check of free moving.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper reprocessing, which is user error, misuse, and / or abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: DRILL/BURR ATTACHMENT FOR 2.35MM SHAFTS
• Common Device Name: 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: 9078430
• Report Number: 8030965-2019-68076
• Device Sequence Number: 3169580
• Product Code: HWE
• UDI-Device Identifier: 07611819928909
• UDI-Public: 07611819928909
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 05.001.123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 10/07/2019; 11/27/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/24/2019; 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention