MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORT POLYAX SCR 5.5 7.0 X 55MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	199723755
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) 2020, during an unknown surgery, the screws were finally tightened when the screw head part of the thread broke off.The correction key became deformed as well.The surgeon removed, and replaced the 2 screws, inserted a rod and new innies, then tightened them.Procedure was successfully completed without surgical delay.There was no patient harm/consequences.Concomitant device reported: unknown tightener (part# unknown, lot# unknown, quantity unknown).Unknown rods (part# unknown, lot# unknown, quantity unknown); unknown tightener (part# unknown, lot# unknown, quantity unknown).This report is for one (1) expedium verse spine system fenestrated cortical fix polyaxial screw 5.5 7.0 x 55mm.This is report 3 of 3 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (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.H10 additional narrative: d10: device returned d11: concomitant products 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.5.5 exp verse fen scr 7.0x55 (part.No: 199723755, lot.No: 246118, qty: 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that one of the reduction tabs was broken but not properly as intended and the other reduction tab looks good without any damage.There was some dry bone cement left inside the cannulated screw.Thus, the complaint is being confirmed.The complaint is being confirmed for 5.5 exp verse fen scr 7.0x55 (part.No: 199723755, lot.No: 246118) as one of the reduction tabs of the received screw got broken.While a definitive root cause cannot be determined, it is possible that the tab of the screw might have encountered unintended forces.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Based upon these results, 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.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot = > the dhr of product code 199723755s, lot 246118, was reviewed and was part of the bounding on the nonconformance nr-0127286 with no link to the complaint description.The lot was released conform to specifications on july 18, 2019.The dhr was electronically reviewed.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 synthese 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: 5.5 exp verse fen scr 7.0x55 (part.No: 199723755, lot.No: 246118, qty: 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that one of the reduction tabs was broken but not properly as intended and the other reduction tab looks good without any damage.There was some dry bone cement left inside the cannulated screw.Thus, the complaint is being confirmed.Device failure/ defect was found.Dimensional inspection: dimensional inspection of the received device was not performed at cq due to the post manufacturing damage and geometry of the device design.Documentation/ specification review: no design issues or discrepancies were found during this investigation.Complaint was confirmed.Investigation conclusion: the complaint is being confirmed for 5.5 exp verse fen scr 7.0x55 (part.No: 199723755, lot.No: 246118) as one of the reduction tabs of the received screw got broken.While a definitive root cause cannot be determined, it is possible that the tab of the screw might have encountered unintended forces.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Based upon these results, 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.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot: the dhr of product code 199723755s, lot 246118, was reviewed and was part of the bounding on the nonconformance (b)(4) with no link to the complaint description.The lot was released conform to specifications on july 18, 2019.Qty.(b)(4).The dhr was electronically reviewed.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
Additional event information.This complaint involves three (3) devices.

• Brand Name: EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORT POLYAX SCR 5.5 7.0 X 55MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10823763
• Report Number: 1526439-2020-02166
• Device Sequence Number: 17036511
• Product Code: MNI
• UDI-Device Identifier: 10705034402895
• UDI-Public: (01)10705034402895
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/01/2020

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 Expiration Date: 05/31/2024
• Device Model Number: 199723755
• Device Catalogue Number: 199723755S
• Device Lot Number: 246118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 11/16/2020; 12/07/2020; 12/09/2020
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 12/01/2020; 12/07/2020; 01/01/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 EXP VERSE FEN SCR 7.0X55; 5.5 EXP VERSE FEN SCR 7.0X55; 5.5 EXP VERSE FEN SCR 7.0X55; UNKNOWN RODS; UNKNOWN RODS; UNKNOWN TIGHTENER; UNKNOWN TIGHTENER; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY