MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/125 DEG TI CANN TFNA 380MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.129S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remained implanted; as such explant date is not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 or Problem Description
It was reported that during an unknown procedure on (b)(6) 2018, the surgeon experienced difficulty when trying to disassemble the proximal femoral nailing system (tfna) handle from the end of the nail after the nail had been implanted.They were using the standard handle in this case and they had a difficult time trying to unscrew the connecting screw that holds the nail and handle together during insertion, proximal targeting, etc.It sounds like there was quite a bit of soft tissue pushing against the medial side of the handle which in turn applies bending/twisting force on the connecting screw and nail threads causing them to bind excessively.There was no surgical delay.Procedure successfully completed.The patient outcome was not provided.This report is for one (1) 11mm/125 deg ti cann tfna 380mm/left - sterile.This is report 2 of 3 for complaint (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was conducted.Manufacturing location: (b)(4), manufacturing date: 25-jan-2018, expiration date: 31-dec-2027: part number: 04.037.129s, 11mm/125 deg ti cann tfna 380mm/left- sterile, lot number: h549398 (sterile), lot quantity 6: work order traveler met all inspection acceptance criteria.Inspection sheet, in-process/inspect dimensional/final met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev c was reviewed and determined to be conforming.Packaging bom was reviewed and all components issued met current defined requirements.Scn supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component parts reviewed: component parts were not reviewed because the complaint condition was related to difficulty trying to unscrew the nail from the insertion handle and, therefore, dhr reviews of the raw materials would not be relevant to the reported condition.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative 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.

• Brand Name: 11MM/125 DEG TI CANN TFNA 380MM/LEFT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7866989
• Report Number: 2939274-2018-53749
• Device Sequence Number: 1337957
• Product Code: HSB
• UDI-Device Identifier: 10886982096432
• UDI-Public: (01)10886982096432
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

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 Model Number: 04.037.129S
• Device Catalogue Number: 04.037.129S
• Device Lot Number: H549398
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 09/12/2018
• Patient Sequence Number: 1