MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.258S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.It is unknown when device broke.Date of implantation is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review has been requested.(b)(4).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 the patient underwent hip surgery on (b)(6) 2018.One titanium (ti) cannulated trochanteric fixation nail advanced (tfna) and one tfna helical blade were removed and the patient was revised to a tfn.The original implantation procedure was performed on an unknown date.At a follow-up appointment on an unknown date, the patient complained of pain and an x-ray was done which revealed the nail was broken with no malfunction of the blade.Implants were removed without difficulty.Procedure was completed successfully with no reported delay.Patient's status is stable.Concomitant device reported: tfna helical blade 10mm sterile (part: 04.038.300s, lot: h540343, quantity: 1) this report is for a 12mm/130 deg ti cann tfna 380mm/right-sterile.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device history record (dhr) review : part number: 04.037.258s; synthes lot number: h517685; release to warehouse date: december 20, 2017; expiration date: october 31, 2017; manufacturing site: synthes (b)(4); no nonconformance records (ncrs) were generated during production.The material was reviewed and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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/130 DEG TI CANN TFNA 380MM/RIGHT-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: 7630586
• Report Number: 2939274-2018-52590
• Device Sequence Number: 1872016
• Product Code: HSB
• UDI-Device Identifier: 10886982097385
• UDI-Public: (01)10886982097385
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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 Model Number: 04.037.258S
• Device Catalogue Number: 04.037.258S
• Device Lot Number: H517685
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 07/13/2018
• 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