WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNIVERSAL CHUCK WITH T-HANDLE; MISC, SURGICAL, ORTHO, INSTRUMENT
|
Back to Search Results |
|
Catalog Number 393.100 |
Device Problems
Device-Device Incompatibility (2919); Device Handling Problem (3265)
|
Patient Problems
No Consequences Or Impact To Patient (2199); Not Applicable (3189)
|
Event Date 09/18/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Complainant part is not expected to be returned for manufacturer review/investigation.State: (b)(6).Without a lot number, the device history records review could not be completed as no product was received.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.
|
|
Event Description
|
Device report from synthes reports an event in (b)(4) as follows: it was reported that part number 393.100/universal chuck with t-handle was not working/gripping the steinman pin during repeated tries.Surgery delayed only three minutes due to the reported.Unknown if fragments were generated or if procedure was successfully completed by an alternative device.Concomitant device reported: unknown steinmann pin (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) device.This report is for one (1) universal chuck with t-handle.This report is 1 of 1 for (b)(4).
|
|
Manufacturer Narrative
|
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.H11 corrected information: b4, h6.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.
|
|
Search Alerts/Recalls
|
|
|