MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE LIFT TORQUE HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2878-90-010
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported while we were expanding the lift cage, the surgeon noticed that the handle was not torquing out.Appeared that the cage had reached its maximum height but the handle was just turning.He continues turning and it finally torqued out.The entire episode lasted 15-20 seconds.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).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.Visual examination of the torque handle revealed no apparent abnormalities.Torque handle was then mechanically tested.This device was within specifications and did not feature any damage and functions as intended.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No root cause analysis is necessary at this time as no product failures have been identified during the course of this investigation.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONCORDE LIFT TORQUE HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8560049
• Report Number: 1526439-2019-51589
• Device Sequence Number: 16540941
• Product Code: LXH
• UDI-Device Identifier: 10705034506968
• UDI-Public: (01)10705034506968
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2019

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 Model Number: 2878-90-010
• Device Catalogue Number: 287890010
• Device Lot Number: BR610932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1