MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC AO/ASIFA^© REAMING ATTACHMENT F/BPL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number	530.780
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device date of manufacture is unknown; therefore, udi: (b)(4).The manufacturing location is unknown.Device manufacture date is unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the attachment device was dismantling.It was reported that there were no delays in the surgical procedure.It was not reported whether a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown but was noted to have occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch 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.Udi: (b)(4).The manufacturer location was documented as unknown in the initial report.The location has been updated to waldenburg.Contact office name/address has been updated accordingly to reflect the correct manufacturing facility.The device manufacture date was documented as unknown in the initial report.It has been updated to 7/18/07.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the device failed the check tool coupling - pin was missing and would not retain gauge sm 000114, ball bearings were corroded and the pin was missing from the locking mechanism.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal wear and improper device maintenance.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: AO/ASIFA^© REAMING ATTACHMENT F/BPL
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8349472
• Report Number: 8030965-2019-61066
• Device Sequence Number: 16707571
• Product Code: GEY
• UDI-Device Identifier: 07611819137219
• UDI-Public: 7611819137219
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 530.780
• Device Lot Number: 1697855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1