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Device Problem
Unintended Movement (3026)
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Patient Problems
Failure of Implant (1924); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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1 unknown screws trauma: pfna/unknown lot.Part and lot number are unknown; udi number is unknown.Manufacture date unknown.A device history record review was requested.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 (b)(4) reports an event in (b)(6) as follows: it was reported that the device was used in original surgery for proximal humeral fracture on (b)(6) 2017.When the (b)(6) female patient underwent the surgery, the proximal humeral plate was applied.As the patient complained pain on the fractured area, it was found on (b)(6) that a screw (part number unknown) had been backed out of the plate.The backed-out screw and the plate were explanted, and then other implants were implanted.The procedure was completed successfully.The x-rays (date of x-rays unknown), shows the screw migrated.Concomitant device: 1x lockscr ø3.5 self-tap l42 tan , 412-118s / l343717, 1x lockscr ø3.5 self-tap l40 tan, 412-117s / l416285 , 1x lockscr ø3.5 self-tap l38 tan, 412-116s / l295107 , 1x lockscr ø3.5 self-tap l36 tan, 412-115s / l329484 , 1x lockscr ø3.5 self-tap l36 tan, 412-115s / l384891 , 1x lockscr ø3.5 self-tap l32 tan, 412-112s / l186802 , 1x lockscr ø3.5 self-tap l30 tan, 412-111s / l339589 , 1x lockscr ø3.5 self-tap l28 tan, 412-110s / l432454 , 1x lockscr ø3.5 self-tap l26 tan, 412-109s / l347791.This report is for 1 unknown screws trauma.This is report 2 of 2 for (b)(4).
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Manufacturer Narrative
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A device history record review was performed for the subject device: 1x lockscr ø3.5 self-tap l42 tan , 412.118s / l343717.Release to warehouse date: 16.Mar.2017 expiry date: 01.Mar.2027 manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.1x lockscr ø3.5 self-tap l40 tan, 412.117s / l416285.Release to warehouse date: 23.May.2017 expiry date: 01.May.2027.Manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.1x lockscr ø3.5 self-tap l38 tan, 412.116s / l295107.Release to warehouse date: 13.Feb.2017 expiry date: 01.Feb.2027.Manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.1x lockscr ø3.5 self-tap l36 tan, 412.115s / l329484.Release to warehouse date: 09.Mar.2017 expiry date: 01.Mar.2027.Manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.1x lockscr ø3.5 self-tap l36 tan, 412.115s / l384891.Release to warehouse date: 02.May.2017 expiry date: 01.Apr.2027.Manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.1x lockscr ø3.5 self-tap l32 tan, 412.112s / l186802.Release to warehouse date: 12.Dec.2016 expiry date: 01.Dec.2026.Manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.1x lockscr ø3.5 self-tap l30 tan, 412.111s / l339589.Release to warehouse date: 15.Mar.2017 expiry date: 01.Mar.2027.Manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.1x lockscr ø3.5 self-tap l28 tan , 412.110s / l432454.Release to warehouse date: 31.May.2017 expiry date: 01.May.2027.Manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.1x lockscr ø3.5 self-tap l26 tan, 412.109s / l347791.Release to warehouse date: 22.Mar.2017 expiry date: 01.Mar.2027.Manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product development investigation was performed for the subject device: 9x screws returned in a slight used condition.X-ray review did show that a screw had been backed out.Therefore complaint is confirmed.As it is not clear which screws did migrate we did check the device history record.Based on dhr-review we could not find any deviation and do conclude that no manufacturing related failure could have led to this complained issue.Visual inspection and dhr-review provided.No further investigation provided as it is not clear which screws migrated and screws slight worn.The material was determined to be conforming at the time of manufacture based on review of the dhrs.Tabulated product drawing was reviewed during this investigation.No product design issues or discrepancies were observed.Replication (functional test) of the reported complaint condition was not able to be performed at customer quality (cq) due to post manufacturing wear consistent with implantation and explantation.A dimensional inspection of features relevant to this complaint could not be obtained due to post manufacturing wear consistent with implantation and explantation.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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Search Alerts/Recalls
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