MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS ALIGNMENT DEVICE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	279726400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4), unknown.The 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 that on an unknown date, while threading in the alignment guide, it would not go all the way down to align with the screw shank because of screw extension crowding.The surgeon tried to use the wrench to force it down and the tip of the alignment guide fractured.Procedure was successfully completed with no surgical delay.Patient outcome is unknown.This complaint involves one (1) device.
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 inspection at the microscopic level revealed that the fracture was located at the device¿s distal tip.The broken part of the device¿s tip was not returned.The device features two vertical fractures at the distal tip which is the thinnest section of the device.Based on these observations, it is believed that the device¿s tip experienced high amount of stresses during impaction to result in it fracturing.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.The root cause of the device breaking its tip cannot be determined from the sample and the information provided.A potential root cause may be high forces inadvertently placed on the device¿s tip during impaction, exerting enough force to result in the fracture.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: MIS ALIGNMENT DEVICE
• 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: 8777053
• Report Number: 1526439-2019-51818
• Device Sequence Number: 2374522
• Product Code: LXH
• UDI-Device Identifier: 10705034199481
• UDI-Public: (01)10705034199481
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/21/2019

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: 279726400
• Device Catalogue Number: 279726400
• Device Lot Number: GM4675401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1