MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 4.0 PLY SCRW 4.0X14; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	1020-40-114
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been 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
It was reported that on (b)(6) 2020, while placing the c7 screw, the surgeon tapped with a 4.0 tap and as he was doing the final turn on the 4.0x14 screw the screw sheared off below the poly head.The shank was recovered and they skipped that level.Patient had giant cell neoplasm with a solid aneurysmal bone cyst.He was treated with denosumab which makes the cyst hard.The bone was extremely hard at this level.Posterior cervical c6-t2.The screw shank was drilled out and recovered.Procedure was successfully completed with a ten (10) minute surgical delay.Patient outcome is unknown.Concomitant device reported: screwdriver (part# unknown, lot# unknown, quantity unknown); drill (part# unknown, lot# unknown, quantity unknown).This report is for one (1) 4.0 ply scrw 4.0x14.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Visual inspection: the 4.0 ply screw 4.0x14 (p/n:102040114, lot #: 236997) was returned and received at us cq.Upon visual inspection, the screw was broken at the most proximal thread and the broken portion was returned.The threads were observed to be deformed and there was a foreign substance most likely bone cement on the threads of the screw.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Std polyaxial screw 4.0x08-50.Std shank 4,0x08-50.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the 4.0 ply screw 4.0x14 (p/n:102040114, lot #: 236997).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces on the device.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: the dhr of product code: 102040114.Lot: 236997.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on 21.03.2019.Qty: 398.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.H6: patient code 3191 used to capture modified surgical procedure.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: 4.0 PLY SCRW 4.0X14
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10575044
• Report Number: 1526439-2020-01774
• Device Sequence Number: 19637364
• Product Code: NKG
• UDI-Device Identifier: 10705034512242
• UDI-Public: (01)10705034512242
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2020

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: 1020-40-114
• Device Catalogue Number: 102040114
• Device Lot Number: 236997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/08/2020; 10/20/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/16/2020; 10/22/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK-SCREWDRIVER; UNKNOWN DRILL BITS; UNK-SCREWDRIVER; UNKNOWN DRILL BITS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Weight: 64