MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC LARGE QUICK COUPLING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.015

Device Problem Detachment Of Device Component (1104)

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

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Udi: lot/serial unknown.(b)(4).Device manufacture date: the device manufacture date is unavailable.The manufacturing site name and address were unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 that during a l5-s2 posterior fusion surgical procedure using an expedium 5.5 and the expedium power platform it was observed that after inserting all the screw devices with power, and disengaging the driver, it was noticed a small silver bead fell out of the large quick coupling device and no instruments could be retained in the chuck.It was reported that all pieces were kept.It was not reported if there was a delay in the procedure due to the event.It was not reported if there was a spare device available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.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.Device was used for treatment, not diagnosis.Correction: udi: (b)(4).It was documented in the previous report stated the serial number was unknown.The serial number ((b)(4)) has been updated in this medwatch report.The manufacturer location was documented as unknown in the initial report.The location has been updated to waldenburg.Contact office name/address have been updated accordingly to reflect the corrected manufacturing facility.It was documented in the previous report that the date of manufacture (dom) was unknown.The dom (jul 19, 2011) has been updated to reflect the date the device was manufactured.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: LARGE QUICK COUPLING
• 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: 7519452
• MDR Text Key: 108441147
• Report Number: 8030965-2018-53805
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 7611819107168
• UDI-Public: (01)7611819107168
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.015
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1