MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CORTICAL FIX FENESTRATED, 7.0 X 45MM; SUTURE,NONABSORBLE,STEEL,MONO/MULTIFILAMENT,STERILE

Model Number	186727745
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	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that the screw head disengaged from the screw shaft while inserting the screw.There was no extra force used.Concomitant device: unknown screwdriver (part# unknown, lot# unknown, quantity 1).This report is for one (1) cortical fix fenestrated, 7.0 x 45mm.This is report 1 of 1 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.H10 additional narrative: d4: lot number and expiration date updated.G1: physical manufacturer updated.H3, h6: a product investigation was conducted: investigation flow: device interaction / functional.Visual inspection: the mis ti cfx fen poly 7x45 (part # 186727745 / lot # 267263) was received at us cq.The screw was received disassembled.The head and cap were still attached, but the flex ball and the shank were unattached.The flex-ball appears to have been deformed inward.Due to the deformation, it is now oblong in nature.There were light scratches on the screw shank, but no other defects.Functional test: functional testing was performed with the screw assembly.Due to the deformation on the flex ball, the flex ball was not able to mate with the screw head or shank.Can the complaint be replicated with the returned device(s)? yes; screw was received unattached and remained unattached.Dimensional inspection: screw shank dimensions were measured since dimensional inspection could not be performed on the deformed flex ball.Conclusion: the overall complaint was confirmed for the received mis ti cfx fen poly 7x45.Although no definitive root-cause can be determined its possible the device experienced unintended forces as evidenced by the deformed flex ball.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: the dhr of product code: 186727745.Lot : 267263.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 01.16.2020.Qty: (b)(4).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.
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: h4.H11 corrected data: g1.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: CORTICAL FIX FENESTRATED, 7.0 X 45MM
• Common Device Name: SUTURE,NONABSORBLE,STEEL,MONO/MULTIFILAMENT,STERILE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10106033
• Report Number: 1526439-2020-01092
• Device Sequence Number: 11445567
• Product Code: PML
• UDI-Device Identifier: 10705034282671
• UDI-Public: 10705034282671
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2020

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: 186727745
• Device Catalogue Number: 186727745
• Device Lot Number: 267263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 07/23/2020; 07/28/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 07/24/2020; 07/29/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWDRIVERS