OBERDORF SYNTHES PRODUKTIONS GMBH 1.8MM TI VA LCKNG BUTTRESS PIN WITH T8 STARDRIVE RECESS/12MM; SCREW, FIXATION, BONE
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Catalog Number 04.210.082S |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/15/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Patient¿s identifier and weight is unknown.Additional device product code: hrs.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.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 europe reports an event in (b)(6) as follows: it was reported that osteosynthesis was applied to distal radius fractures on (b)(6) 2017.Hardware removal surgery was performed on (b)(6) 2018 and an incomplete bone-healing area was found where variable angle-locking compression (va-lcp) buttress pin in question was not locked to va-lcp plate during the original surgery.The explant surgery was completed without a delay, and there was no adverse consequence to the patient.Surgeon commented that in the original surgery, the surgeon had difficulty in connecting the buttress pin to the plate.The plate¿s hole concerned was the most distal on the radius side.Although he properly followed the surgical instructions, the buttress pin just span around and could not be tightened to the plate.So, he decided to leave the buttress pin unlocked and completed the original surgery.On the contrary, bone healing was confirmed on the ulnar side where screws had been locked.The surgeon commented that he had completed the original surgery without any technical error.Patient outcome reported as stable.This report addresses the intra-operative issue of buttress pin not connecting to the plate during the original surgery.The postoperative revision due to non-union has been captured under linked complaint (b)(4).This report is for one (1) va-lcp buttress pin.This is report 2 of 2 for complaint (b)(4).
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Manufacturer Narrative
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Dhr review was completed.Part: 04.210.082s, lot: 8191899 , manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: 10.Dec.2012, expiry date: 01.Dec.2022.The device history record shows this lot of 74 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.Non-sterile 04.210.082 / 6815123 was manufactured in us, monument.Item: 04.210.082, lot: 6815123 , released qty: (b)(4), released date: 08 nov 2011, manufacturer: monument.All inspections were performed and passed per ns045461, rev c.There were no ncs or reworks generated during the production of this lot.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Customer quality conducted an investigation of the returned devices.Investigation selection: investigation site: (b)(4), selected flow: 2.Device interaction.Visual inspection: the visual investigation of the complained locking screw shows that the threaded flanks at the conical screw head are rounded and worn.Furthermore, the anodized color was abraded.The threads on the shaft are in good condition.The plate is in a used condition with slight scratches on the surface.The threads of the most distal hole are also damaged.Functional test: because of the damages on the plate and as well on the screw, the functional test cannot be reproduced.Dimensional inspection: because of the damages the complaint relevant dimensions cannot be checked to print specifications anymore.Drawing/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no drawing/specification review is needed.Material review: raw material certified test reports were checked and meet the specification.Dhr review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.Failure in material or production could not be detected.The measurable dimensions are well documented and all within the valid specifications.Summary: the received condition of the devices is concordant with the complaint description and the complaint condition is confirmed.Based on the provided information and afterwards, we are not able to determine the exact cause of this complaint.A possibly reason could be that the threads of the plate got damaged by trying to set the drill sleeve.This consequently could be the reason, why the buttress pin couldn¿t be locked and spun around.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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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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Event Description
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It was further reported that there was no delay in surgery due to the reported event.
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