SYNTHES GMBH 3.5MM TI LOCKING SCR SLF-TPNG W/STARDRIVE RECESS/36MM-STER; ROD,FIXATION,INTRAMEDULLARY
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Catalog Number 412.115S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Malunion of Bone (4529); Physical Asymmetry (4573)
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Event Date 01/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Additional product code ktt.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot.Part: 412.115s.Lot: 67p7423.Manufacturing site: (b)(4).Release to warehouse date: sep.09, 2020.Expire date: aug.01, 2030.A manufacturing record evaluation was performed for the finished device 412.115s lot: 67p7423 and no non-conformances were identified.(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 (b)(6) reports an event as follows: it was reported on an unknown date that the patient will undergo for a revision surgery due to weak bone quality, the reduction was not sufficient, or the anchoring mechanism of the nail was not worked properly on (b)(6) 2020.The surgeon will remove the multiloc implants and implant the artificial bone head.On (b)(6) 2020, the patient underwent the open reduction internal fixation surgery for proximal humerus fracture.The surgeon used the multiloc implants in the surgery and the surgery was completed successfully.After the surgery within 1 week, on an unknown date, the fixation by the nail were lost and the bone head was varus.It was unknown if the revision surgery completed successfully and any consequences with the patient.Concomitant device reported: multiloc end cap f/multiloc hn/phn extend (product code: 04.019.005, lot number: 59p0303, qty :1).Multiloc screw ø4.5 l36 tan (product code: 04.019.036, lot number: 46p7709, quantity :1).Multiloc screw ø4.5 l42 tan (product code: 04.019.042, lot number: 55p7289, quantity :1).3ockscr ø3.5 self-tap l32 tan (product code: 412.112, lot number: 69p0822, quantity :1).Lockscr ø3.5 self-tap l36 tan (product code: 412.115, lot number: 67p7423, quantity :1).Lockscr ø4 l26 f/nails tan dblue (product code: 04.005.416, lot number: 6l93655, quantity :1).Lockscr ø4 l26 f/nails tan dblue (product code: 04.005.416, lot number: 7l27803, quantity :1).This complaint involves eight (8) devices.This report is for (1) 3.5mm ti locking scr slf-tpng w/stardrive recess/36mm-ster.This report is 5 of 8 for (b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).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.H10 additional narrative: b3.D11.H3, h4, h6: device history lot.Part: 412.115s.Lot: 67p7423.Manufacturing site: grenchen.Release to warehouse date: 09.Sep.2020.Expire date: 01.Aug.2030.A manufacturing record evaluation was performed for the finished device 412.115s lot: 67p7423 and no non-conformances were identified.H11: b3, g1, h6.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.B3, g1, h6.
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