MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 7.0X45; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	199723745
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
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.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, two fractured verse screws at the s1 level occurred.Revision surgery was performed by removing all unitized set screws (x6), rods 65mm ti (x2).Part of the broken 7mm verse screws (x2) the distal screw shanks remained in the vertebral body of s1.The l4 & 5 screws remained in the patient and reused for the revision procedure.2x s2ai 8x80mm screws were inserted and connected with a cocr rod to the existing l4 and 5 screws.No further information provided.This report is for one (1) 5.5 exp verse fen scr 7.0x45 this is report 2 of 2 for (b)(4).
Event or Problem Description
Concomitant device reported: 5.5 exp verse unitized set scr (part# 199721001, lot# vh1321, quantity 2).5.5 exp verse unitized set scr (part# 199721001, lot# vp1211, quantity 2).5.5 exp verse unitized set scr (part# 199721001, lot# ve1112, quantity 1).5.5 exp verse unitized set scr (part# 199721001, lot# vp1331, quantity 1).2 pk ti rod prebent, 5.5 x65mm (part# 179772065, lot# bdmj3t4, quantity 2).5.5 exp verse fen scr 7.0x45 (part # 199723745, lot # 112584, 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.H3, h6: a product investigation was conducted.Visual inspection: 5.5 exp verse fen scr 7.0x45 was received at us cq.Upon visual inspection at cq, it is observed that the screw shank got broken at the thread near to the neck part.The broken part was not received at us cq.The received shank part got stuck in head part without movement.The rest of the device shows normal wear which would not contribute to the complaint condition.Thus, the complaint is being confirmed.Dimensional inspection: dimensional inspection of the received complaint device was not performed at cq due to post manufacturing damage.Documentation/ specification review: the relavnt drawing(s) was reviewed; expedium verse 5.5 system fenestrated screw assembly.Expedium verse 7x45-80 fenestrated cf shank.No design issues or discrepancies were found during this investigation.Complaint is confirmed, but, the embedded condition of the device cannot be confirmed without any x-rays or scan reports showing the embedded device.Investigation conclusion: visual inspection, dimensional inspection, and document specification review of the received device was performed at cq.The complaint is being confirmed as it is observed that the screw shank got broken at the thread near to the neck part.While a definitive root cause could not be determined, it is possible that the device might have encountered unintended forces.During the investigation no unidentified product design/manufacturing issues or discrepancies 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.H3, h4, h6: a device history record (dhr) review was conducted: the dhr of product code 199723745, lot 215284, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on september 13, 2018.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.

• Brand Name: 5.5 EXP VERSE FEN SCR 7.0X45
• 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: 9836412
• Report Number: 1526439-2020-00722
• Device Sequence Number: 3068550
• Product Code: MNI
• UDI-Device Identifier: 10705034402918
• UDI-Public: (01)10705034402918
• 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
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: 199723745
• Device Catalogue Number: 199723745
• Device Lot Number: 215284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/13/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2 PK TI ROD PREB 5.5 X65MM; 2 PK TI ROD PREB 5.5 X65MM; 5.5 EXP VERSE FEN SCR 7.0X45; 5.5 EXP VERSE UNI SET SCR; 5.5 EXP VERSE UNI SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR
• Outcome Attributed to Adverse Event: Required Intervention