SYNTHES GMBH 2.0MM CANNULATED DRILL BIT/QC 150MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Catalog Number 310.221 |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problems
Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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Reporter facility name: (b)(6) medical center.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation surgery for a foot navicular bone fracture with the guide wire and drill bit.During the surgery, the guide wire broke because the bone quality was very good.The surgeon used the drill bit to remove the fragment of the guide wire, but the drill bit broke.The surgeon tried to remove the fragments, but some fragments remained in the patient.The surgery was completed with fifty (50) minute surgical delay.The revision surgery has not been scheduled.Concomitant devices reported: guidewire ø1.1 l150 sst (part number 292.623s, lot 60p5509, quantity 1).This report involves one (1) 2.0mm cannulated drill bit/qc 150mm.This is report 2 of 2 for (b)(4).
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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.H3, h4, h6- the tips of the cannulated drill bits are completely broken off as complained.A part of circa 4mm at the tips is broken off.It was only three broken parts / fragment returned for investigation.Besides, the instruments presents normal signs of use.Dimensions were checked and found to comply with the specifications.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, material and visual criteria at the time of release with no issues documented during the manufacturing process.As part of depuy synthes¿ quality process all devices are manufactured, inspected, and released to approved specifications.The complaint condition is confirmed as the tips of the drill bits are broken off.This production lot conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.The correct material was used, and the hardness parameters were within the specifications.There were no issues during the manufacture of this product that would contribute to this complaint condition.The damage occurred is determined to be postproduction/acceptance criterias.A definitive root cause for the drill bit breaking could not be determined based on the provided information.However, we do suppose that the device encountered unintended forces, such as excessive force application during its use, which finally resulted in the breakage.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance device history lot : part: 310.221, lot: f-29903, manufacturing site: selzach, supplier: (b)(4).Release to warehouse date: 25 may 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance related to the reported complaint condition were identified.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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