DEPUY MITEK LLC US BARREL TORNADO BURR 5.5MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
|
Back to Search Results |
|
Catalog Number 283889 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
|
Patient Problems
No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
|
Event Date 12/05/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It was reported by the affiliate in (b)(6) that before an unspecified surgical procedure, it was observed that the packaging of their barrel tornado burr had a hole on its extremity.Affiliate stated that it was impossible to use the device since the material became non sterile.The case was completed by using another one.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown but was noted to have occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Manufacturer Narrative
|
Date received by manufacturer on follow-up 2 should be january 31, 2019.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
|
Additional information received from the affiliate on 01/10/2019 stating that the event occurred on (b)(6) 2018 and it was discovered pre-operative.There was no patient involvement or harm.The affiliate also described the nature of the defect as a perforation on the tip of the packaging for 1 burr.
|
|
Manufacturer Narrative
|
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 medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed.Given the information provided we cannot discern a definitive root cause for the reported failure.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.A process deviation occurred during the processing of this lot, however the deviation involved a process unrelated to the complaint condition.Therefore, our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point, 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.Udi: (b)(4).
|
|
Manufacturer Narrative
|
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.Corrected data: investigation summary was corrected to reflect the device return and investigation investigation summary: the complaint device was received and inspected.The complaint can be confirmed.The device was received inside the alleged damaged packaging.It was observed that the side of the thermoformed blister that is closest to the proximal end of the barrel burr was breached, and a circular portion seemed to have been punched off.Mitek package development and supplier quality were consulted for further insight into the failure observed.Both groups verified that this type of failure has been observed previously, and extensive root cause analysis from past investigations has revealed that this type of failure can occur when the device experiences a high drop on the observed damaged end.Additional investigation was performed by supplier quality via pia, and the packaging is currently under design changes to mitigate the risk of this failure occurring.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.A process deviation was initiated during the processing of this lot of product, however the process involved in the deviation does not relate to the complaint condition.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point, 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.Udi: (b)(4).
|
|
Search Alerts/Recalls
|
|
|