ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN¿¢, CMN LAG SCREW TAP, SHORT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number N/A |
Device Problems
Break (1069); Fracture (1260); Activation, Positioning or Separation Problem (2906); Device Damaged by Another Device (2915); Activation Problem (4042)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The implantation and explantation dates are left empty as the device involved in this complaint is an instrument.For the same reason, expiration date is also not captured.This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.The manufacturer did not receive surgical reports, x-rays for review.Other documents were received and will be reviewed as part of ongoing investigation.Lot numbers were received and the device history records were reviewed and found to be conforming.The process of gaining necessary information is still ongoing.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
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Event Description
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Intraoperative complication involving the fracture of the instrument.No broken pieces were left in the patient and there was no surgical delay.
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Manufacturer Narrative
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Investigation results were made available.Review of event description: it was reported that the tip of the cephalomedullary lag screw reamer - short ref: 00-2490-003-64 broke off during the procedure.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the tip of the cephalomedullary lag screw reamer - short ref: 00-2490-003-64 broke off during the procedure.No product was returned, hence visual and dimensional evaluation could not be performed; therefore, the condition of the part is unknown.Based on the investigation the reported event cannot be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
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Event Description
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No event update.Investigation results are now available.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The product was returned for investigation.The shaft of the instrument shows some scratches.The threaded area of the instrument shows some damages: some of the thread are worn off and flattened, while other broke off.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical records were not provided.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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