MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS SINGLE INNER SETSCW; SCREW,FIXATION,BONE

Catalog Number 186715000

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that this was a psf (posterior spinal fusion) in l3-iliac fixation treating l5 burst fracture with viper system on (b)(6) 2019.The procedure was completed without surgical delay.As an outpatient s/he came to see the surgeon on (b)(6) 2019.It was found that the setscrews (unk) had come off and caused a rod to be off the correct position.The patient will undergo a revision procedure on (b)(6) 2019.No further information is available.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity 1) unknown polyaxial screws (part# unknown, lot# unknown, quantity unknown) this report is for one (1) unknown locking/set screws this is report 3 of 4 for (b)(4).

Event Description

Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity 1).This is report 3 of 6 for (b)(4).

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 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.

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.Investigation summary background: it was reported that this was a psf (posterior spinal fusion) in l3-iliac fixation treating l5 burst fracture with viper system on (b)(6) 2019.The procedure was completed without surgical delay.As an outpatient s/he came to see the surgeon on (b)(6) 2019.It was found that the setscrews (unk) had come off and caused a rod to be off the correct position.The patient will undergo a revision procedure on (b)(6) 2019.No further information is available.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity 1).This complaint involves four (4) devices.Investigation flow: device interaction/functional.Visual inspection: the mis single inner screw (p/n: (b)(4), lot #: 245498) was returned and received at us cq.Upon visual inspection, it was observed that the threads were stripped and there were scratches on the device but has no impact on the functionality of the device.No other issues were identified with the returned device.Functional test: the functional test was performed on the returned device.The inner screw was able to assemble with the returned 5.5 ti cortex fix 7 x 45 mm (p/n: 186731745) with no defects identified.Upon assembly, the inner screw was observed to be loose because of the stripped threads, which could have caused the backed out complaint condition.The complaint can be replicated with the returned device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.The device received was stripped.Hence confirming the allegation.Investigation conclusion: the complaint condition is confirmed for the mis single inner screw (p/n: (b)(4), lot #: 245498).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to 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.A review of the device history record.Device history lot the dhr of product code 186715000, lot 245498, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on (b)(6) 2019.Qty.458.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.

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.Manufacture date provided for reporting.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: MIS SINGLE INNER SETSCW
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle MA 02400 ; SZ 02400
• MDR Report Key: 9580977
• MDR Text Key: 189458824
• Report Number: 1526439-2020-00361
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/25/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 186715000
• Device Lot Number: 245498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Manufacturer Received: 12/25/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 01/17/2020; 02/12/2020; 02/13/2020
• Supplement Dates FDA Received: 01/17/2020; 02/12/2020; 02/14/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN RODS; UNKNOWN RODS; UNKNOWN RODS; UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention