MAUDE Adverse Event Report: SYNTHES MONUMENT PERCUTANEOUS INSERTION HANDLE FOR FEMORAL NAILS-EX; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number	03.010.401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.No patient involvement reported.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: dhr review: part # 03.010.401.Synthes lot # 1751300.Supplier lot # 1751300.Release to warehouse date: 09 dec 2009.Supplier: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the percutaneous insertion handle for femoral nails was broken at the nail interface (tab that connects to nail is broken off) found in sterile processing and a t.Handle was noted to be spinning and no locking and turning during general inspection.This complaint is for one device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Customer quality conducted an investigation of the returned device.The insertion handle was returned with the entire tab broken off.This complaint is confirmed.The t-handle was repaired by service and repair and then returned to the customer.A visual inspection, drawing and device history record review were performed as part of this investigation.Further material and hardness testing is not applicable at this time as they were tested at the time of manufactured and confirmed to have no issues through the dhr review.Visual inspection revealed that the entire tab had broken off the insertion handle, additionally the entire device shows signs of wear.A dimensional analysis is not applicable at this time as the relevant features were broken off and not returned.Drawings were reviewed and were determined to be suitable for the intended design, application and dimensional conformity when used as recommended.Dhr review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Whether this complaint can be replicated is not applicable because the device was returned broken.A definitive root cause could not be determined but it is likely that the device bent over repeated use, eventually leading to the breakage.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.

• Brand Name: PERCUTANEOUS INSERTION HANDLE FOR FEMORAL NAILS-EX
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6985625
• Report Number: 1719045-2017-11125
• Device Sequence Number: 11062090
• Product Code: LXH
• UDI-Device Identifier: 10886982068538
• UDI-Public: (01)10886982068538(10)1751300
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.010.401
• Device Lot Number: 1751300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1