MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS SINGLE INNER SETSCW; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Catalog Number 186715000

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: complaint summary: surgery was performed due to a loose screw which was replaced.The implant(s) was not returned and instead the investigation will be done based on the supplied image(s).The image(s) was reviewed and the complaint condition could be confirmed as one screw is not as well seated as the other from the image provided.As the implant(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 on an unknown date that the patient had a surgery due to a loose screw.It was unknown if the surgery was completed successfully.The patient outcome was unknown.Concomitant device reported: viper2 lordotic rod-80mm (part# 186788080, lot# mf4134201, quantity 2).Mis ti cfx fen poly 5x45 (part# 186727545, lot# 281373, quantity 1).Mis ti cfx fen poly 5x45 (part# 186727545, lot# 268421, quantity 1).Mis ti cfx fen poly 5x40 (part# 186727540, lot# 268027, quantity 2).Mis single inner sets cw (part# 186715000, lot# 266262, quantity 1).Mis single inner sets cw (part# 186715000, lot# 275215, quantity 1).Mis single inner sets cw (part# 186715000, lot# 275213, quantity 1).This complaint involves one (1) device.This report is for (1) unknown screws.This is report 1 of 1 (b)(4).Related product complaint: (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.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

This report is for one (1) mis single inner setscw.

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.D2: additional device product codes: kwp;kwq;nkb;mni;osh.H3, h6: a product investigation was conducted.Visual inspection: the physical product mis single inner setscw (p/n: 186715000, lot #: 266819) was returned and received at us cq with (b)(4).Upon visual inspection, it was observed that distal broken end of the viper2 x25 set screw inserter (p/n: 286735400, lot #: mf4134201) from (b)(4) was struck inside the screw.The reported condition of loose can be confirmed from the provided images.No other issues were identified with the returned device.Functional test: functional test was performed on the device.Pliers were used in an attempt to remove the broken piece of the set screw inserter, however the fragment was unable to be removed.The complaint replication was unable to be performed.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Investigation conclusion: the complaint condition of loose can be confirmed for the mis single inner setscw (p/n: 186715000, lot #: 266819).The broken piece of the inserter (p/n: 286735400, lot #: mf4134201) from (b)(4) was struck in the screw.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.H3, h4, h6: a device history record (dhr) review was conducted: the dhr of product code: 186715000, lot : 266819.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 13.01.2020.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.

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.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.B3: unknown date in 2020.

• Brand Name: MIS SINGLE INNER SETSCW
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10500086
• MDR Text Key: 205898288
• Report Number: 1526439-2020-01612
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2020
• 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: 266819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 12/09/2020
• Patient Sequence Number: 1
• Treatment: MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; MIS TI CFX FEN POLY 5X40; MIS TI CFX FEN POLY 5X45; UNKNOWN RODS; VIPER2 LORDOTIC ROD-80MM
• Patient Outcome(s): Required Intervention