MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 340MM/LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.055S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2019
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 revision of a trochanteric fixation nail advanced (tfna) nail due to breakage at the proximal end where the helical blade is placed.The non-union of the fracture was the reason the hardware is believed to have failed.The date of the initial implant was six (6) months prior.The procedure outcome and patient status were unknown.Concomitant devices: unknown tfna helical blade (part # unknown, lot # unknown, quantity 1), unknown locking screw (part # unknown, lot # unknown, quantity unknown), unknown tfna end cap (part # unknown, lot # unknown, quantity 1).This report is for one 10 mm/130 deg ti cann tfna 340mm/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.Visual inspection performed at customer quality (cq) identified the nail broke at the proximal hole.The break is jagged and oblique.There is also some suspected drill marks on one side of the proximal hole.No new issues were identified.Based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Review of the manufacturing record evaluation showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot manufacturing date: 17-mar-2017.Expiration date: 28-feb-2027.Part number: 04.037.055s, 10mm/130 deg ti cann tfna 340mm/left ¿ sterile.Lot number: h319383 (sterile).Component part(s) reviewed: part number: 04.037.942.2, lock prong 130 degree, tfna, bp55.Lot number: l287746.Part number: 04.037.912.4, wave spring, shim ended, bp55.Lot number: h249468.Part number: 04.037.912.3, tfna lock drive, bp58.Lot number: h277536.Part number: 21127, timoagri16.00, bp80.Lot number: h156482.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.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
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.H10 additional narrative: b5: updated concomitant devices reported 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
Updated concomitant devices reported: tfna helical blade (part # 04.038.390, lot # h845633, quantity 1) unknown locking screw (part # unknown, lot # unknown, quantity unknown) unknown tfna end cap (part# unknown, lot# unknown, quantity 1).

• Brand Name: 10MM/130 DEG TI CANN TFNA 340MM/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: 9591055
• Report Number: 2939274-2020-00190
• Device Sequence Number: 534860
• Product Code: HSB
• UDI-Device Identifier: 10886982096111
• UDI-Public: (01)10886982096111
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2019

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: 04.037.055S
• Device Catalogue Number: 04.037.055S
• Device Lot Number: H319383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 12/21/2019
• Supplement Date Received by Manufacturer: 01/30/2020; 02/10/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/07/2020; 02/11/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA FENESTRATED HELICAL BLADE 90MM; UNK - END CAPS: TFNA; UNK - END CAPS: TFNA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - END CAPS: TFNA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR