|
Catalog Number 273205110 |
Device Problem
Torn Material (3024)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/11/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4) a follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Rep reported this complaint to synthes.Reporting a couple damaged instruments and trial that occurred in a case today, (b)(6).Cougar inserter: both cross threaded in case 273511300 lot: ag2066621.273511300 lot: ag2066617.Cougar 10mm 5deg small trail: medial lateral trial threads cross threaded 273205110 lot: t0911, it was reported that during an anterior lumbar interbody fusion (alif) at l4-l5 on (b)(6) 2016, the inserter tip stripped.When inserting the second inserter into the trial, the inserter tip stripped and the trial became damaged.No fragments generated.Another set was available and surgery was successfully completed without patient harm.A four minutes surgical delay was reported.Devices and implant are available for return.Sales consultant confirmed no additional information.
|
|
Manufacturer Narrative
|
One (1) small 5 degree trial (product code: 2732-05-110, lot no: t0911) was returned to the complaint handling unit (chu) for evaluation.Visual examination of the returned trial revealed notable signs of wear and the leading thread on two of the trial hole threads are significantly worn-out.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.With the information provided, a definitive root cause for torn threads on the cage inserter and the small 5 degree trial cannot be determined.However, possible root cause of torn threads may be due to incorrect component positioning or inadequate thread engagement of the inserter into the small trial and inadvertently cross threading.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|
|