MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP DUAL-INNER SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179722000
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the rods fractured at t12 level and screws broken at l5 level.Revision surgery to replace rods and extend construct to s1 and pelvis was performed.No problems during procedure.This report is for one (1) exp dual-inner setscrew.This is report 7 of 8 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.The dhr of product code (b)(4), lot apccdh, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on february 15th, 2013.Qty.(b)(4).The dhr was electronically reviewed.Visual inspection: the sfx,5.5,ti, med, size a5 (part #(b)(4), lot # om8677, mfg # apccdh) was received at us cq with a small portion of the inner setscrew broken off since there is visible missing material.The set crew is stripped and nicked.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was not performed as relevant features are significantly deformed.Document/specification review: the following drawing(s) was reviewed; expedium di closure assembly.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).

• Brand Name: EXP DUAL-INNER SETSCREW
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9452899
• Report Number: 1526439-2019-52662
• Device Sequence Number: 2972772
• Product Code: NKB
• UDI-Device Identifier: 10705034070070
• UDI-Public: (01)10705034070070
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2019

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: 179722000
• Device Catalogue Number: 179722000
• Device Lot Number: APCCDH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 12/16/2019; 12/19/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 12/17/2019; 12/20/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXP DUAL-INNER SETSCREW
• Outcome Attributed to Adverse Event: Required Intervention