MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 6.0X35; ORTHOSIS,PEDICLE SPINAL FIXATION

Model Number	199723635
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 on an unknown date that the screw was found broken before the revision surgery.There was no patient involvement.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity 1), unknown screws (part# unknown, lot# unknown, quantity 1), unknown set screws (part# unknown, lot# unknown, quantity 1).This complaint involves two (2) devices.This is report 1 of 1 for (b)(4).Related product complaint: (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: updated data-b6, d4, h4.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
Updated: concomitant device reported: expedium verse spine system unitized set screw 5.5 (part #: 199721001, lot #: wc1321, quantity 3); expedium verse spine system unitized set screw 5.5 (part #: 199721001, lot #: vj1231, quantity 2); expedium spine system pre-bent spinal rod 5.5 x 65mm (part #: 179772065, serial or lot #: (b)(6)quantity 2); 5.5 exp verse fen scw 6.0 (199723645, lot unknown, quantity 4); 5.5 exp verse unitized set (199721001,lot unknown, quantity 1).
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: b5/d11.H3, h4, h6 investigation summary: visual inspection: the device was received at us cq.The device was found to be broken off at proximal portion of the screw and the broken piece was returned.The provided xrays/images also shows the breakage of the screws.The complaint can be confirmed for the reported condition.Device failure/defect identified? yes.Dimensional inspection: diameter of screw at middle : 6 +/-0.1 mm.Measured dimensions: ø at middle of the broken piece: 5.94 mm; conforming.Document/specification review: drawing.Investigation conclusion: no definitive root cause was able to be determined as the circumstances surrounding the event are unknown.However, it is possible that condition was due to early excessive strain by patient and/or unintended forces.  during the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.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.Device history: part number: 199723635, lot number: 185057, the product was released on march 5, 2018.Qty.(b)(4), the dhr was electronically reviewed.The dhr of product code 199723635, lot 185057, was reviewed and no non-conformance was observed during the manufacturing process.H11 corrected data d10.H4.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: 5.5 EXP VERSE FEN SCR 6.0X35
• Common Device Name: ORTHOSIS,PEDICLE SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10122993
• Report Number: 1526439-2020-01115
• Device Sequence Number: 2850640
• Product Code: MNI
• UDI-Device Identifier: 10705034403106
• UDI-Public: 10705034403106
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2020

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: 199723635
• Device Catalogue Number: 199723635
• Device Lot Number: 185057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 06/26/2020; 07/20/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 06/26/2020; 07/21/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 EXP VERSE FEN SCR 6.0X35; 5.5 EXP VERSE FEN SCR 6.0X45; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; MMSI ROD PREBENT, 5.5 X65MM, T; MMSI ROD PREBENT, 5.5 X65MM, T; UNKNOWN SCREWS; 5.5 EXP VERSE UNITIZED SET SCR; MMSI ROD PREBENT, 5.5 X65 MM, T; UNKNOWN SCREWS
• Patient Age: 75 YR