MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS TI CFX FEN POLY 9X40; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	186727940
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	06/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: mni.Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/ or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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 (b)(6) 2020, upon inserting a 9.0 x 40 mm cortical screw into s1, it appeared that the screwdriver became loosened from the screw head.The driver was removed and it was observed that the tip of the driver sheared off.It was then attempted to remove the screw from the patient by using various known common techniques but in doing so the poly head of the screw came off of the half inserted screw.Multiple attempts were made to remove the remaining screw but were unsuccessful.The top portion of the screw head was burred/ cut off to allow room for the accommodation of steps needed to finish the case.Procedure outcome is unknown.There was patient harm/consequence.This complaint involves two (2) devices.This report is for one (1) cortical fix fenestrated, 9.0 x 40mm.This is report 1 of 2 for (b)(4).
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6- the complaint device was not received for investigation.The following investigation is based on the image(s) provided in the attachment(s) the image(s) were reviewed, and the complaint condition of broken (2+ pieces) could be confirmed since the screw was clearly broken into multiple pieces.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MIS TI CFX FEN POLY 9X40
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10272405
• Report Number: 1526439-2020-01333
• Device Sequence Number: 860192
• Product Code: PML
• UDI-Device Identifier: 10705034282886
• UDI-Public: (01)10705034282886
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2020

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 Model Number: 186727940
• Device Catalogue Number: 186727940
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 07/22/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: XPDM QUICK-CON SI POLY SCWDRVR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR