Catalog Number 314.746S |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Device used for treatment, not diagnosis.Patient information not available for reporting.Other udi: (01) unknown (10) lot unknown, udi is unavailable.This report is for unknown reamer/irrigator/aspirator /unknown lot number.Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.The 510k#: is unknown.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided.Based on the information available, 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.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 on an event in (b)(6) as follows: it was reported that reamer/irrigator/aspirator broke off under the reamer head.No patient harm reported.There was a surgery prolongation of 30 minutes reported.This complaint involves 1 part.1x unk reamer head, part/lot unknown.This report is 1 of 1 for (b)(4).
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Manufacturer Narrative
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Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided.Device 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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Part number now applicable.Other udi:(b)(4) unknown (10) lot number unknown.Device 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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Update: 03oct2017 part number reported.
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Manufacturer Narrative
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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.Synthes manufacturing location was discovered upon receipt of subject device.Device 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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A product evaluation/investigation summary was performed.The investigation of the complaint articles indicates that: it was reported that reamer/irrigator/aspirator broke off under the reamer head.No patient harm reported.There was a surgery prolongation of 30 minutes reported.The following device were returned to cq: part# 314.746s, lot number unknown ¿ ria tube assembly, for ria drive shaft minimum length 520mm, for 314.743, sterile.The complaint condition is confirmed.A visual inspection and drawing review were performed as part of this investigation.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended and the risk assessment, where applicable, was found to adequately address the complaint condition.No new defects or malfunctions were observed on any of the returned instruments.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the instrument is already broken which prevents the device from functioning as intended.Please note an unk reamer head, part/lot unknown was also returned and stated to be concomitant, therefore no further investigation is required on the instrument at this time.Investigation methods/evaluation results: during use a drive shaft is attached to the corresponding length reamer/irrigator/aspirator (ria) tube assembly and a reamer head and then connected to a drive unit.The ria system is intended for use to clear the medullary canal, to size the medullary canal, to harvest bone and bone marrow, and to remove infected and necrotic bone.Upon visual inspection of the device the tip of the reamer is broken off between the shaft and the reamer head.Also, the reamer is stuck into the drive shaft.There is a permanent bend on along the length of the instrument, along with scratch marks; indicating the instrument has been used.No new defects or malfunctions were observed on the returned instrument.A definitive root cause could not be determined, a possible root cause is the application of high mechanical force on it during the surgery leading to the failure.A dhr review could not be done at the lot number is unknown.Dimensional analysis for the instrument is not applicable due to post-manufacturing damage.A material and hardness is not applicable now as the root cause of the failure is related to application of high mechanical force on it during the surgery and not that associated with hardness/material of the instrument.Drawings was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The complaint is confirmed.Device 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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