No patient involvement reported.Date of event is unknown.Device is an instrument and is not implanted/explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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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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.A device history record (dhr) review was conducted for part number: 357.399, lot number: h578142: part manufacturing date: 06 march 2018, manufacturing site: elmira, part expiration date: n/a, nonconformance noted: n/a: a review of the device history record revealed no complaint related anomalies.The device history record shows lot h578142 of 3.2mm guide wires was processed through the normal manufacturing and inspection operations with no rework or non-conformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot h509619 met all specifications with no issues documented that would contribute to this complaint condition.A product investigation was conducted.The guide wire (part: 357.399 lot: h578142, mfg: 06-march-2018) was received with the reported condition of ¿visual deformed/bent: rm.¿ at customer quality, the returned guide wire (part: 357.399lot: h578142, mfg: 06-march-2018) was inspected and the complaint was confirmed.The following investigations were performed: labeling & packaging; damage: visual (appearance not as expected): visual inspection performed at customer quality observed that guide wire was significantly bent at its distal portion.The received condition agrees with the complaint description and the complaint was confirmed.Relevant drawings for the returned device were reviewed (both current and from the time of manufacture): top-level drawing for drill tip guide wire and determined to be suitable for the intended design and application when used as recommended.A device history review was performed for the returned instrument¿s lot number and no ncrs, mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.While no definitive root cause could be determined, it is likely that any unintended forces encountered by the device during shipping or handling could have contributed to both damaged package and bent condition of guide wire.Also based on the dhr review it was confirmed that the device was delivered out from manufacturing site without any defects.Therefore, it is likely that any unintended forces encountered by the device during transit could have contributed to this complaint condition.During the investigation, no product design or manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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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