MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.159S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 a patient was initially implanted with tfn-advanced proximal femoral nailing system (tfna) on (b)(6) 2019.Postoperatively patient complained of pain and clicking in her hip.X-ray taken on an unknown postoperative date revealed that the titanium cannulated trochanteric fixation nail implant was broken.Patient underwent a hardware removal on (b)(6) 2019 and was implanted with larger trochanteric nail.Per surgeon device did not come out easily.Surgeon had to remove the blade and then the entire nail came out in one piece (fractured completely on one half and nearly fractured all the way through but held together just enough to come out in one piece).It is unknown if there was surgical delay.Procedure outcome and patient status is unknown.Concomitant device reported: tfna helical blade (part# 04.038.300, lot # h540343, quantity #1).Unknown - screws: (part # unknown , lot # unknown, quantity #2).This report is for one (1) tfna nail.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history records review was completed for part: 04.037.159s, lot: h476325.Manufacturing location: monument, manufacturing date: oct 18, 2017.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product investigation was completed.The 11mm 130 degree titanium cannulated trochanteric fixation nail implant was returned along with the associated helical blade and two (2) screws.The nail is crack across the walls of its upper opening for the helical blade.On one side, it is split all the way across, and the locking mechanism for the helical blade is bent into the fracture.On the other side it is cracked part way through.The lower portion of the nail has two small grooves in it, presumably from the screws used to secure it.The complaint cannot be confirmed as broken, but the device is cracked and deformed.A dimensional inspection was not performed due to post-manufacturing damage.The complaint could not be confirmed.The received 11mm 130 degree titanium cannulated trochanteric fixation nail was cracked and deformed but did not break.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it is possible that the device encountered unintended forces.No new, unique or different patient harms were identified as a result of this evaluation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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/130 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: 8519299
• Report Number: 2939274-2019-57492
• Device Sequence Number: 1846818
• Product Code: HSB
• UDI-Device Identifier: 10886982096678
• UDI-Public: (01)10886982096678
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: 04.037.159S
• Device Catalogue Number: 04.037.159S
• Device Lot Number: H476325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/10/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 98