Catalog Number 398.41 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Device used for treatment, not diagnosis.No patient involvement reported.Date of event: unknown.(b)(4).Device is an instrument and is not implanted/explanted.Date returned to manufacturer.A service & repair evaluation/review was attempted; waiting for approval.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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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Service & repair documented that it was reported that two reduction forceps would not hold, and the bone spreader is broken.The issues were identified in sterile processing.There was no reported patient or procedure involvement.This complaint involves three devices.This report is 1 of 3 for (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Additional narrative: a product development investigation was performed for the subject devices.Two 398.41 reduction forceps lot numbers a7oa42 and a7ia52 were returned and reported to no longer hold.One 399.10 lot number 2028 bone spreader was returned and reported to be broken.This complaint condition was likely caused by frequent repeated use and possible rough handling during surgery or sterile processing; however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection and drawing review were performed as part of this investigation.This complaint is confirmed.No new malfunctions were observed during the course of this investigation.The 398.41 reduction forceps are an instrument routinely used in the 2.4mm lcp distal radius system (technique guide) and the 399.10 bone spreader is a general instrument with numerous applications.The forceps were returned and reported to not hold and the bone spreader was reported to be broken.These conditions are confirmed; the leaf spring of the bone spreader has broken off and was not returned, and a few teeth on each of the ratcheting mechanisms of the forceps are worn causing the mechanism to slip.The handles of the forceps are also somewhat bent.Lot a7oa42 was manufactured in 10/2005 and is over eleven years old.Lot a7ia52 was manufactured in 12/1999 and is over seventeen years old.The balance of the returned devices is fairly worn condition consistent with age of the devices.Drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned devices does agree with the complaint description.The complaint condition for the forceps can be replicated.Whether the complaint condition for the bone spreader can be replicated is not applicable.All measurements have been performed by calipers.The devices were received through service and repair as unrepairable where the complaint condition was also confirmed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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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Device was used for treatment, not diagnosis.A service and repair evaluation was performed for the subject device.The customer reported the forceps would not hold.The synthes repair technician reported the locking sprocket was loose and bent at the sprocket.¿bent¿ is the reason for repair.The item is not repairable per the inspection sheet.The cause of the complaint issue is unknown.The service and repair evaluation confirmed the complaint condition.The item will be forwarded to synthes customer quality for additional investigation.A service and repair history record review could not be completed because the subject device is a lot/batch controlled item.Therefore, a device history record review was performed for the subject device lot number a7oa42, synthes lot number 5104180.Manufacturing location: (b)(4).The review showed that there are two different manufacturing lots associated with lot #a7oa42: ba# 902328 and ba# 903202.Ba# 902328: manufacturing date: 20-oct-2005.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records.All (b)(4) parts of the lot were checked 100% for important features and for function at the final inspection on 19-oct-2005.Ba# 903202: manufacturing date: 21-oct-2005.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records.All (b)(4) parts of the lot were checked 100% for important features and for function at the final inspection on 18-oct-2005.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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