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WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM; PLATE,FIXATION,BONE
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| Model Number |
223.581 |
| Medical Device Problem Code |
Adverse Event Without Identified Device or Use Problem (2993)
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| Health Effect - Clinical Codes |
Bone Fracture(s) (1870); No Code Available (3191)
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Type of Reportable Event
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Serious Injury
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Additional Manufacturer Narrative
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Patient identifier: (b)(6).Additional device product codes: hwc, ktt.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.(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.
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Event or Problem Description
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It was reported that on (b)(6) 2020, the patient underwent removal of the locking compression plate (lcp) system due to nonunion of the radius.The patient was originally implanted with an lcp system on (b)(6) 2019.The patient outcome was reported as good after the procedure.Concomitant devices reported: lcp one-third tubular plate with collar 5 holes/57mm (part number 241.351, lot h750374, quantity 1), screws: cortex (part number unknown, lot unknown, quantity 7), screws: locking (part number unknown, lot unknown, quantity 2).This report involves one (1) 3.5mm lcp plate 8 holes 111mm.This is report 1 of 10 for (b)(4).This product complaint, (b)(4), is related to (b)(4).
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Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device manufacture date not available at this time, dhr has not been completed.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 or Problem Description
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It was reported that on (b)(6) 2020, the patient underwent removal of the locking compression plate (lcp) system due to nonunion of the radius.The patient was originally implanted with an lcp system on (b)(6) 2019.The patient outcome was reported as good after the procedure.Concomitant devices reported: 3.5mm lcp plate 8 holes 111mm (part number 223.581, lot h745081, quantity 1), screws: cortex (part number unknown, lot unknown, quantity 7), screws: locking (part number unknown, lot unknown, quantity 2).This report involves one (1) lcp one-third tubular plate with collar 5 holes/57mm.This is report 3 of 10 for (b)(4).This product complaint, (b)(4) is related to (b)(4).
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Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Part number: 241.351, lot number: h750374, part manufacture date: november 29, 2018, manufacturing location: (b)(4), part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of lcp one-third tubular plate with collar 5 holes/57mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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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