MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM / TI CANN FRN / GT 360MM / LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.033.067S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.(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 on (b)(6) 2019, the patient underwent a hardware removal due to subtrochanteric non-union and a broken femoral recon nail (frn).The patient had been implanted on (b)(6) 2019 however, an implant failure of frn at an unknown distal recon screw hole was observed.The procedure outcome is unknown.There were no patient consequences reported.Concomitant devices: unknown end cap (part # unknown, lot # unknown, quantity 1), 6.5mm ti recon screw with t25 stardrive 80mm (product code: 04.003.026 lot #: 1l92918 qty: 1), 6.5mm ti recon screw with t25 stardrive 95mm (product code: 04.003.029 lot #: 1l92908 qty: 1), 5.0mm ti locking screw 40mm- for im nails (product code: 458.940 lot #: 3l22191 qty: 1), 5.0mm ti locking screw 50mm- for im nails (product code: 458.950 lot #: 7969804 qty: 1).This report is for one 10mm / ti cann frn / gt 360mm / left - sterile.This is report 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The 10 mm/ ti cann frn/ gt 360 mm/ left-sterile (p/n: 04.033.067, lot #: l826190) was returned and received at us cq.Upon visual inspection, it was observed that the device was broken at the third recon screw hole and foreign materials were observed on the distal locking screw holes.There were scratches on the device but that is consistent with the device use and explantation.No other issues were identified with the returned components of the device.No dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design and breakage of the device.The complaint condition is confirmed for the 10 mm/ ti cann frn/ gt 360 mm/ left-sterile (p/n: 04.033.067, lot #: l826190).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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 history lot part: 04.033.067s-us.Lot: l826190.Manufacturing site: bettlach.Release to warehouse date: 18.May 2018.Expiry date: 30.April 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A dhr review was not performed for this pi.No record of this part number ever having been processed at the monument facility.European lot number.Please reassign this task to the correct group.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: 10MM / TI CANN FRN / GT 360MM / 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: 9611411
• Report Number: 2939274-2020-00300
• Device Sequence Number: 16813730
• Product Code: HSB
• UDI-Device Identifier: 10886982272119
• UDI-Public: (01)10886982272119
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• 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): 12/26/2019

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: 04.033.067S
• Device Catalogue Number: 04.033.067S
• Device Lot Number: L826190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 02/13/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - END CAPS; UNK - SCREWS: LOCKING; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 69