MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.013.000
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Additional device code: hwc.Date of implant is unknown.Date of explant is unknown.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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
(b)(6) reports following: it was reported that the spiral blade locking screw/end cap of our right antegrade femoral nail (rafn) distal locking option (with spiral blade and locking screw superiorly) unscrewed three months post-operative.No instability was found neither patient pain was declared.Surgeon could see callus formation at fracture site under x-rays.Thus, he's not worried about non-union.No other issue than the worry of over time migration of the end cap in the knee join.Surgeon has then decided to remove the loosen end cap to avoid future possible pain (prophylactic surgery).No other intervention was done.Surgeon did the original surgery and he is 100% sure the adequate end cap was tightened as per surgical procedure recommendation.Concomitant devices reported: locking screw (part # unknown, lot # unknown, quantity # unknown).This report is for one (1) ti end cap t40 strdrv 0 mm ext retro femoral nail-ex sprl bld.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part # 04.013.000s, synthes lot number: h128994, supplier lot number: (b)(4): expiration date: 31 jul 2025, release to warehouse date: 26 aug 2016, manufactured by synthes monument: no non-conformance reports (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 sub-components, which would contribute to this complaint condition.A product investigation was performed.This complaint was unable to be confirmed because no x-rays showing visual evidence of the reported complaint condition were provided.The returned end cap was received at customer quality (cq) with wear marks consistent with implantation and explantation.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition.The returned end cap is an implant available for use in the titanium cannulated retrograde/antegrade femoral nail expert nailing system indicated to stabilize fractures of the distal femur and the femoral shaft.Instructions for use can be found in surgical technique guide.The material was determined to be conforming at the time of manufacture based on review of the dhr.Relevant drawing was reviewed during this investigation.No product design issues or discrepancies were observed.The major thread diameter of the returned end cap measured at cq which is within specification per relevant drawing.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.
Additional Manufacturer Narrative
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
Additional concomitant devices reported: blade (part # unknown, lot # unknown, quantity # unknown), nail (part # unknown, lot # unknown, quantity # unknown).

• Brand Name: TI END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD
• 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: 7122279
• Report Number: 2939274-2017-50314
• Device Sequence Number: 1358080
• Product Code: HSB
• UDI-Device Identifier: 10886982087348
• UDI-Public: (01)10886982087348(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/16/2017

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 Expiration Date: 07/31/2025
• Device Model Number: 04.013.000
• Device Catalogue Number: 04.013.000S
• Device Lot Number: H128994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 12/19/2017; 02/13/2018; 02/13/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 01/17/2018; 02/13/2018; 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 163