OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM-STERILE; PLATE,FIXATION,BONE
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Catalog Number 04.210.124S |
Device Problem
Break (1069)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.(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 Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that a procedure was performed on an unknown date with a variable angle volar distal radius plate.On (b)(6) 2018, the patient¿s affected area became slightly swollen.On (b)(6) 2018, the patient reported an uncomfortable feeling and x-ray was used to discover that the distal screw was broken.The implants were removed on (b)(6) 2018 and another unknown device was implanted.Surgical outcome is unknown.The patient outcome was reported as stable.This report is for one (1) 2.4mm ti va locking screw stardrive 24mm-sterile.This is report 2 of 2 for (b)(4).
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Event Description
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It was reported that a procedure was performed on an unknown date with a variable angle volar distal radius plate with no allegation.On (b)(6) 2018, the patient¿s affected area got a little bit swollen.On (b)(6) 2018, the patient reported uncomfortable feeling and the hospital found by x-rays that one (1) variable angle locking screw and five (5) unknown locking screws were broken.The patient had no idea about any events that might applied great force to the affected area.The implants were removed on (b)(6) 2018 and another device made by other company was introduced.There was no surgical delay and procedure was completed successfully.The patient outcome is reported as stable.Concomitant devices reported: 2.4mm va-lcp plate (part#04.111.730s, lot#l939113, quantity#1).
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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.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.Device evaluation: visual inspection: the head of a 2.4mm va locking screw was retuned which was identified as (04.210.124s).This was unable to be confirmed as the screw shaft was not returned, as such the screw length was unable to be determined.The received condition agrees with the complaint description of broken, as such the complaint is confirmed.The specific circumstances at the time of the issue are unknown, therefore, it cannot be definitively determined if external factors (use error, misuse/abuse/postoperative trauma, etc.) impacted the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Material review: a material and/or hardness review was not possible as a review of the device history record(s) was not possible as the device¿s lot number is unknown.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Conclusion the complaint condition is confirmed as a broken 2.4mm va screw head was received.This investigation no product design or manufacturing issues were observed 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 history lot , part: 04.210.124s, lot: l853541, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 16.Apr.2018, expiry date: 01.Apr.2028.Manufacturing location: monument manufacturing date: 19-mar-2018, part number: 04.210.124, 2.4mm ti va locking screw stardrive 24mm, lot number: h591622 (non-sterile).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.Component part(s) reviewed: part number: 04.211.024.999, 2.8mm ti screw blank 24mm 02.7 variable angle w/sd8 lot number: h509515 part number: 04.210.120.999, 208mm screw blank 31mm no head turn/no point/w/sd8 lot number: h495563 work order traveler met all inspection acceptance criteria.Part number: 23032, tialnbci2.78 lot number: h494830 certified test report supplied by perryman company dated 23-oct-2017 was reviewed and determined to be conforming.Lot summary report dated 30-oct-2017 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.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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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 evaluation: investigation flow: broken visual inspection: the head of a 2.4mm va locking screw was returned which was identified as (04.210.124s).This was unable to be confirmed as the screw shaft was not returned, as such the screw length was unable to be determined.The received condition agrees with the complaint description of broken; as such, the complaint is confirmed.The specific circumstances at the time of the issue are unknown, therefore, it cannot be definitively determined if external factors (use error, misuse/abuse/postoperative trauma, etc.) impacted the complaint condition.Dimensional inspection: no dimensional inspection was possible due to post-manufactured damage.Document/specification review: as the lot number is unknown, review of drawings from the time of manufacture is not possible.The following drawing, reflecting the current revision, was reviewed: - 2.4mm variable angle locking screw, self-tapping, stardrive recess during the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Material review: a material and/or hardness review was not possible as a review of the device history record(s) was not possible as the device¿s lot number is unknown.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Conclusion the complaint condition is confirmed as a broken 2.4mm va screw head was received.The system risk document was found to adequately address the complaint condition.During this investigation, no product design or manufacturing issues were observed 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.
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