SYNTHES GMBH TI LCP PROX LATERAL TIBIA PL 5 HOLES/140MM/LEFT-STERILE; PLATE,FIXATION,BONE
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Catalog Number 422.221S |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.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 that on (b)(6) 2021, the patient underwent for a removal surgery due to bone union.During the removal surgery, the screw head was stripped.The most proximal screw was removed, and the surgeon tried to remove the remaining distal screw with an extraction screw, but it was idled.As a result, the extraction screw was used again, and the screw could be removed.Originally, the patient underwent the surgery for left tibial plateau fracture with the plate and screws on (b)(6) 2020.The removal surgery was completed successfully within 30-minutes delay.The patient outcome was unknown.Concomitant device reported: lcp-plt 4.5/5.0 le 5ho l140 tan (part# 422.221s; lot# 6l20180; quantity: 1).Unknown extraction screw (part# unknown; lot# unknown; quantity: 1).Unknown screwdriver (part# unknown; lot# unknown; quantity: 1).This complaint involves three(3) devices.This report is for (1) ti lcp prox lateral tibia pl 5 holes/140mm/left-sterile.This report is 1 of 4 for (b)(4).
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Manufacturer Narrative
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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, h4, h6: part: 422.221s, lot: 6l20180, manufacturing site: grenchen, release to warehouse date: 23 october 2019, expiry date: 01 october 2029.A manufacturing record evaluation was performed for the finished device lot , and no non-conformances related to malfunction were identified.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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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Search Alerts/Recalls
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