MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/125 DEG TI CANN TFNA 420MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.033S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: patient id also reported as (b)(6).Device evaluated by mfr: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(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 on (b)(6) 2019, patient underwent device removal due to a broken trochanteric fixation nail advance (tfna) nail.There were no fragments generated from the broken device.Procedure was successfully completed with no delay.Patient outcome is unknown.Concomitant devices: locking screw (part: unknown, lot: unknown, quantity: 2), tfna fenestrated screw 95mm (part: 04.038.195, lot: h691521, quantity: 1).This report is for a 10mm/125 degree titanium (ti) cannulated tfna nail.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.A device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 03-aug-2015, expiration date: 30-jun-2025, part number: 04.037.033s, 10mm/125 deg ti cann tfna 420mm/left ¿ sterile, lot number: 9865741 (sterile), lot quantity: (b)(4).This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component parts reviewed: part number: 04.037.912.2, lock prong 125 degree, tfna, bp55, lot number: 9505317, lot , quantity: (b)(4).Purchased finished goods traveler met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended, bp55, lot number: 7722137, lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Part number: 04.037.912.3, tfna lock drive, bp58, lot number: 9853309, lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Part number: 21127, timoagri16.00, bp80, lot number: 7813438, lot quantity: (b)(4).This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A product investigation was conducted.Visual inspection: the 10 mm/ 125 deg ti cannulated 420 mm/ left - sterile (part # 04.037.033s, lot # 65741, mfg # 03-aug-2015) was received at us cq with the nail broken at the proximal hole where the fenestrated screw is placed.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was completed, the outer diameter of the shaft close to the fracture site measured.This is within specification based on relevant drawing.Document/specification review: the relevant drawing(s) was reviewed.Conclusion: 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 malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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/125 DEG TI CANN TFNA 420MM/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: 8601310
• Report Number: 2939274-2019-57971
• Device Sequence Number: 19335417
• Product Code: HSB
• UDI-Device Identifier: 10886982095916
• UDI-Public: (01)10886982095916
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/13/2019

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 Expiration Date: 06/30/2025
• Device Model Number: 04.037.033S
• Device Catalogue Number: 04.037.033S
• Device Lot Number: 9865741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Initial Date Received by Manufacturer: 04/13/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/05/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA FENESTRATED SCREW 95MM; UNK - SCREWS: LOCKING; TFNA FENESTRATED SCREW 95MM; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention