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OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LCP PROXIMAL TIBIA PL LOW BEND 14 HOLES/206MM/RIGHT PLATE, FIXATION, BONE
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| Catalog Number 04.124.220 |
| Device Problem
Defective Device (2588)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Product complaint (b)(4).
Complainant part returned for manufacturer review/investigation.
Reporter is a synthes rep.
A review of the device history record has been requested.
The investigation could not be completed; 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 when the distributor did the incoming goods checking, opened the packing, noted the device was with 16 holes, the same as 04.
124.
224 as the photo show, checked the label, it shows 14 holes.
There were no adverse consequences to the patient.
It was the wrong hole qty.
This complaint involves one (1) device.
This report is 1 of 1 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, h6: the device was received, the investigation is in progess, 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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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.
Visual inspection: the lcp prox tibpi 3.
5 low bend r 14ho l206 t (p/n: 04.
124.
220, lot #:18p2758) was returned and received at us cq.
Upon visual inspecting the device and reviewing the photographs, it was observed that the laser etches markings of synthes logo, 04.
124.
220, r, 18p2758, ce0123.
The part was received with a label 14 emphasized to demonstrate the part should have 14 holes.
The packaging is not the original packaging specified within the dhr file.
No other issues were identified with the returned device.
Document/specification review: based on the date of manufacture the following drawings, the current and manufactured revision of drawings were reviewed 3.
5 mm lcp low bend proximal tibial plate 4-16 holes.
Investigation conclusion the complaint condition was confirmed for the lcp prox tibpi 3.
5 low bend r 14ho l206 t (p/n: 04.
124.
220, lot #: 18p2758) as the part etched 04.
124.
220, r, 18p2758, ce0123 contains 16 holes.
Here is no indication that a design or manufacturing issue has caused the complaint condition and the root cause was traced to manufacturing error, additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Jabil nonconformance jbl-nr-0004169/ j&j nr-0145270 will investigate noted manufacturing error.
Device history part number: 04.
124.
220, lot number: 18p2758, part manufacture date: 10-oct-2019 , manufacturing location: elmira, 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 proxtibpl 3.
5 low bend r 14ho l206 t 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.
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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