MAUDE Adverse Event Report: SYNTHES MONUMENT 12MM TI END CAP T40 STARDRIVE 5MM EXT FOR FEMORAL NAILS-EX; ROD,FIXATION,INTRAMEDULLARY

Catalog Number	04.003.001
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.(b)(6).(b)(4): unanticipated x-rays were taken to resolve the end cap issue.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: part 04.003.001, lot 5535144.Manufacturing location: supplier (b)(4).Manufacturing date: 09-aug-2007.Part #: 04.003.001, lot#: 5535144 (non-sterile) - 12mm end cap t40 stardrive 5mm ext for femoral nails-ex quantity (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 the product that 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 during stage two removal of external fixator and implantation of retrograde femoral nail procedure on (b)(6) 2016, surgeon selected 5 mm end cap and it would not engage / did not thread into the nail.Then surgeon selected 0 mm end cap however second 5 mm end cap was tested on the back table with the trial retrograde nail (ex rafn nail) and it was engaged as planned and therefore, 0 mm end cap was removed and second 5 mm end cap was inserted without any issue.There was 5 minutes delay in procedure and the surgery was completed successfully and the patient outcome was reported to be as planned.The first malfunctioned 5 mm end cap was tested on the back table with trial ex rafn nail and it would not engage the 5 mm end cap was manually removed with needle holder.Intra operative unplanned x-rays taken to resolve end cap problem and were not available for review.This complaint involves one device.Concomitant devices reported: retrograde femoral nail (part # 04.013.352s, lot # 7316088, quantity # 1), trial ex rafn nail (part # unknown, lot # unknown, quantity #1).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device.The returned end cap has damaged threads.The threads are worn with some small nicks and deformation.The remainder of the device is in good condition.A visual inspection and drawing review were performed as part of this investigation.Use of the end cap is outlined in the titanium cannulated lateral entry femoral recon nail technique guide.The following drawings were reviewed during investigation.Extension end cap - femoral nails ¿ the design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.No definitive root cause was able to be determined.The issue may be related to cross threading of the end cap with the nail and/or handling of the device prior to use.Device was not implanted.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 5MM EXT FOR FEMORAL NAILS-EX
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6167349
• Report Number: 1719045-2016-10905
• Device Sequence Number: 18936231
• Product Code: HSB
• UDI-Device Identifier: 10886982081315
• UDI-Public: (01)10886982081315(10)5535144
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K040336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.003.001
• Device Lot Number: 5535144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2016
• Supplement Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 04.013.352S, RETROGRADE FEMORAL NAIL; TRIAL EX RAFN NAIL, PART, LOT # UNK, UNK, QTY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR