Model Number 130790036 |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2023 |
Event Type
malfunction
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Event Description
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It was reported that the screw-head shows a missing little "tooth" in the screw drive.Discovery was made during primary implantation of a shoulder.Another screw was available and was used without any issue.No surgical delay, no adverse patient consequences.
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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.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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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was returned for analysis.Visual analysis revealed that one of the prongs of the dxtend screw lock d4.5x36mm was found broken, fragment was not returned for evaluation.However, no evidence of the initial condition of the device upon receipt was provided, therefore the reported allegation cannot be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: dhr reportable in germany.Device history record review for (b)(4).Product description: dxtend screw lock d4.5x36mm; product code: 130790036; lot number: 5420455.1) quantity manufactured: (b)(4) units.2) date of manufacture: 09/21/2022.3) any anomalies or deviations identified in dhr: 0 nonconformance recorded on this batch.4) expiry date: 08/31/2027.5) ifu reference: (b)(4).Device history review: 1) quantity manufactured: (b)(4) units.2) date of manufacture: 09/21/2022.3) any anomalies or deviations identified in dhr: 0 nonconformance recorded on this batch.4) expiry date: 08/31/2027.5) ifu reference: (b)(4).
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Search Alerts/Recalls
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