MEDOS INTERNATIONAL SÃ RL CH MIS SINGLE INNER SETSCW; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
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Catalog Number 186715000 |
Device Problems
Unintended Movement (3026); No Apparent Adverse Event (3189)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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510k: this report is for an unknown locking/set 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.The investigation could not be completed, no product was received; 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.
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that during a surgery when loosening of innies, the instrument was burst.It was unknown if the surgery was completed successfully.There was no patient consequence.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 two (2) devices.This report is for (1) unknown locking/set screws.This is report 2 of 2 (b)(4).Related product complaint: (b)(4).
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Manufacturer Narrative
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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: b6: x-rays provided for reporting.Investigation summary: background: updated event description: surgery was performed due to a loose screw which was replaced.The surgeon states that he/she used too much force while repositioning the screw which were too small which is why they came loose.The surgeon did not use a torque screw shaft but the inserter which broke as a result.Patient status is stable.The procedure was successfully completed by placing all implants with new.Updated event description: 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 setscw (part# 186715000, lot# 266262, quantity 1).Mis single inner setscw (part# 186715000, lot# 275215, quantity 1).Mis single inner setscw (part# 186715000, lot# 275213, quantity 1).This complaint involve two (2) devices.H3, h4, h6: device history lot: 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).Investigation flow: device interaction/functional.Visual inspection: the mis single inner setscw (p/n: 186715000, lot #: 266819) was returned and received at us cq.Upon visual inspection, it was observed that distal broken end of the viper2 x25 set screw inserter (p/n: 286735400, lot #: mf4134201) was struck inside the screw.The reported condition of loose cannot be confirmed.No other issues were identified with the returned device.Functional test: the functional test was performed on the returned device.The broken piece that was struck in the screw was tried to pull out with a plier but the broken pieces were hard to be pulled out.The complaint replication was unable to be performed as the inserter tip was broken.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review: mis set screw: 1867-15-000, rev.A.Complaint not confirmed.Investigation conclusion: the complaint condition of loose cannot be confirmed for the mis single inner setscw (p/n: 186715000, lot #: 266819).The broken piece of the inserter 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.H11: d1, d4: brand name, cat.#, udi & lot number 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.
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Event Description
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The initial complaint was reviewed and found to be a duplicate of a device captured on related complaint (b)(4) and is captured on manufacturer report number 1526439-2020-01612.
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Search Alerts/Recalls
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