MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.459S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).A review of the device history record has been requested.The investigation could not be completed; 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 on an unknown date, the patient underwent a revision procedure due to a broken trochanteric fixation nail (tfn) nail and helical blade.Initially, the patient was implanted with the reported devices on december.It is unknown if there was a surgical delay.Surgical outcome is unknown.Concomitant device reported: unknown tfn end caps (part # unknown, lot # unknown, quantity 1), unknown locking screw (part # unknown, lot # unknown, quantity unknown).This complaints involves 2 devices.This report is for 1 14mm/130 deg ti cann tfna 380mm/left-sterile.This report is 2 of 2 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.H10 additional narrative: h3, h4, h6: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot manufacturing location: monument.Manufacturing date: 10-sep-2019, expiration date: 31-jul-2029, part number: 04.037.459s, 14mm/130 deg ti cann tfna 380mm/left-sterile, lot number: 16l0741 (sterile).Component part(s) reviewed: part number: 04.037.912.3, tfna lock drive, lot number: 14l5165, part number: 04.037.912.4, wave spring, shim ended, lot number: h794555, part number: 04.037.942.2, lock prong, 130 degree tfna, lot number: 5l38934, part number: 21127, timoagri16.00, bp80, lot number: 10l8564.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.

• Brand Name: 14MM/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: 10022148
• Report Number: 2939274-2020-02228
• Device Sequence Number: 14156451
• Product Code: HSB
• UDI-Device Identifier: 10886982097637
• UDI-Public: (01)10886982097637
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2020

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: 04.037.459S
• Device Catalogue Number: 04.037.459S
• Device Lot Number: 16L0741
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 05/18/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 14MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE; TFNA FENESTRATED HELICAL BLADE 90MM; UNK - END CAPS: TFN; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention