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OBERDORF SYNTHES PRODUKTIONS GMBH 1.6MM KIRSCHNER WIRE W/TROCAR POINT 285MM; WIRE, SURGICAL
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| Catalog Number 292.180.01 |
| Device Problems
Break (1069); Entrapment of Device (1212)
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| Patient Problem
Foreign Body In Patient (2687)
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| Event Date 08/10/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review / investigation, but has yet to be received.Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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 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 that a (b)(6) year-old patient with a diagnosis of cerebral palsy underwent a bilateral variant femur corrective osteotomy on (b)(6) 2019.Second right osteotomy procedure was performed without any inconvenience.A second approach was performed on the left femur and the specialist inserted the 2.0-tip threaded nail through the block, as indicated by the technique guide.Control radiography was taken to verify position and showed that the nail was very low with respect to the trochanteric epiphysis.When removing the guide needle with cad ii motor in reverse at a moderate pace with the jacobs adapter, it was observed that the threaded tip of the guide was inside the bone in the trochanteric portion.The specialist decided to not remove the fragment that is inside the patient's bone because it does not interfere with osteosynthesis.The split guide of 2.0 was changed to a new one and position of the guide was carried out.The procedure was completed successfully with no delay.There were no patient consequences.Concomitant devices: cad ii motor (part: unknown, lot: unknown, quantity: 1), jacobs adapter (part: unknown, lot: unknown, quantity: 1), plate (part: unknown, lot: unknown, quantity: 2), screws (part: unknown, lot: unknown, quantity: unknown).This report is for a k-wire.This is report 1 of 1 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.H3, h6: investigation summary background: it was reported that a 10-year-old patient with a diagnosis of cerebral palsy, a bilateral variant femur corrective osteotomy is performed.Second right osteotomy procedure is performed without any inconvenience.A second approach is performed on the left femur and the specialist proceeds to insert the 2.0-tip threaded nail through the block, as indicated by the technique.Take control rx to verify position and observe that it is very low with respect to the trochanteric epiphysis.When removing the guide needle with cad ii motor in reverse at a moderate pace with the jacobs adapter, it is observed that the threaded tip of the guide was inside the bone in the trochanteric portion.The specialist decides not to remove the fragment that is inside the patient's bone because it does not interfere with osteosynthesis.The split guide of 2.0 is changed to a new one and position of the guide is carried out and the intervention is continued without any inconvenience.Surgical time is not lengthened.There is no patient involvement.The procedure ends without complications.Rx is not available.The 2.0 guide pin for cls is returned so that the return to quality process is followed.Procedure was successfully completed.Fragments were generated and were removed easily without additional intervention.The fragment was not removed because it was inside the bone in the intertrochanteric portion.And it did not intervene in the osteotomy or in the position of the plate and screws.Patient status is unknown.No patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.) concomitant devices reported: unknown cad ii motor (part# unknown, lot# unknown, quantity# 1), unknown jacobs adapter (part# unknown, lot# unknown, quantity# 1), unknown plate (part# unknown, lot# unknown, quantity# 2), unknown screws (part# unknown, lot# unknown, quantity# unknown).Concomitant devices: unknown tfna nail (part# unknown, lot# unknown, quantity# 1).This complaint involves two (2) devices.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image provided in attachment ¿(b)(4) additional information from j&j employee 14aug2019.¿ the image(s) was reviewed, and the complaint condition is confirmed as the image depicts a broken distal tip of unknown k-wire device.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation was not performed because the lot number is unknown.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H11: d10: complainant part is not expected to be returned for manufacturer review/investigation.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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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.Product code: 292.180.01 lot #: 1l48526 manufacturing site: balsthal release to warehouse date: 11.Sep.2018 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The image(s) was reviewed, and the complaint condition is confirmed as the image depicts a broken distal tip of a k-wire device.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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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