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Catalog Number 211036 |
Device Problem
Degraded (1153)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2024 |
Event Type
malfunction
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.Device was used for treatment, not diagnosis.H10 additional narrative: e3: reporter is a j&j sales representative.D4, h4: the lot number was unknown; therefore, the device manufacture date is unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.(b)(4).
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Event Description
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It was reported by the sales rep in japan that during an arthroscopic bankart repair (abr) for a shoulder dislocation procedure, it was observed that the gryphon 2.4mm drill bit device was used to create holes for an anchor insertion.However, it was difficult to create holes in the bone.The surgeon indicated that the bone was hard at first.Then, it was found that the drill bit was not sharp enough.The drill bit was used to create four holes.The last hole was drilled a little with the k-wire device, and the drill bit was used to create the hole.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.Device was used for treatment, not diagnosis.H10 additional narrative: investigation summary = > the complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Given that no lot/serial number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot/serial number becomes available, the mre review will be performed.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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Search Alerts/Recalls
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