MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 12MM TI END CAP T40 STARDRIVE 10MM EXT FOR FEMORAL NAILS-EX; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.003.002
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight is unknown.Additional product code: hwc.Due to intra-operative issues, the device was not implanted/explanted.Facility information was not provided.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 two different 10 mm end caps would not thread into the nail during a right lateral entry femoral nail procedure on (b)(6) 2017.The surgeon had placed the 9x340 nail and went to place a 10 mm end cap in the proximal portion of the nail.He tried two different 10 mm end caps and neither would thread into the nail.He then went and placed a 15 mm end cap and had no problem getting it to engage and thread in.There was a ten (10) minute surgical delay.The surgery was successfully completed with good patient outcome.Concomitant device report: 9x340 nail (part unknown, lot unknown, quantity 1).This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Dhr review was completed.Part number: 04.003.002, synthes lot number: 5687067 , supplier lot number: n/a , release to warehouse date: 15-apr-2008, expiration date: n/a, manufactured by (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.Visual inspection under 5x magnification at customer quality (cq) on the returned 9+year old implant that is intended for single use only revealed post manufacturing damage in the form of damaged threads.An area on the second most distal thread and third most distal thread have dents/bent in opposite directions which suggests another metallic device was forcibly wedged into the thread form.There also exist wear marks which suggest the device has been handled with pliers or roughly in another manner.The reported complaint condition was not able to be replicated at cq via functional test because the nail involved in the event was not returned.However, the post manufacturing damage on the 9+ year old implant that is intended for single use only could cause or contribute to the reported complaint condition.Therefore, this complaint is confirmed.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Tabulated drawing was reviewed during this investigation.No product design issues or discrepancies were observed.A dimensional inspection on the 9+ year old implant that is intended for single use only was not performed at cq because the post manufacturing thread damage was visually confirmed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 12MM TI END CAP T40 STARDRIVE 10MM EXT FOR FEMORAL NAILS-EX
• 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: 7191193
• Report Number: 2939274-2018-50266
• Device Sequence Number: 1017788
• Product Code: HSB
• UDI-Device Identifier: 10886982081339
• UDI-Public: (01)10886982081339(10)5687067
• Combination Product (Y/N): N
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2017

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 Model Number: 04.003.002
• Device Catalogue Number: 04.003.002
• Device Lot Number: 5687067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 01/15/2018
• Supplement Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR