MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.961S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: added concomitant devices.(b)(4).A device history record (dhr) review was conducted: manufacturing location: (b)(4); manufacturing date: 16-may-2017; expiration date: 30-apr-2027; part number: 04.037.961s, 9mm/130 deg ti cann tfna 400mm/left- sterile; lot number: h366186 (sterile); lot quantity: 6.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.Component parts reviewed: part number: 04.037.912.4, wave spring, shim ended, bp55, lot number: h249484, lot quantity: 1,000; part number: 04.037.942.2, lock prong, 130 degree tfna, bp55, lot number: l376203, lot quantity: 92; part number: 04.037.912.3, tfna lock drive, bp58, lot number: h349799, lot quantity: 80; part number: 21127, timoagri16.00, bp80, lot number: h625377, lot quantity: 1,809 lbs.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.Corrected information from user facility report: brand name.Complainant part is not expected to be returned for manufacturer review/investigation.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
This report is against user facility medwatch number (b)(4).The only information contained in this report is correction or additional information.It was further reported that the removal of the tfna implants actually went very smoothly.Tfna nail fractured with a "greenstick" pattern, it resembles a pediatric diaphyseal fracture pattern (ie.Similar to when you try to snap a small fresh tree branch in half - the "tension" half breaks, and the "compression" side bends).Surgeon is not referring to the bone fracture that the patient had - patient had an "atypical" bisphosphonate related fracture, and not a greenstick fracture.Concomitant device reported: tfna fenestrated screw ( part #: 04.038.190s, lot # h366186, quantity # 1); 5.0mm ti locking screw (part #: 04.005.532, lot # h366186, 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 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.This report is against user facility medwatch number (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
This report is against user facility medwatch number (b)(4).

• Brand Name: 9MM/130 DEG TI CANN TFNA 400MM/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: 8741723
• Report Number: 2939274-2019-58901
• Device Sequence Number: 2371870
• Product Code: HSB
• UDI-Device Identifier: 10886982098214
• UDI-Public: (01)10886982098214
• Combination Product (Y/N): N
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2019

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: 04.037.961S
• Device Catalogue Number: 04037961S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/03/2019; 06/28/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 06/27/2019; 07/18/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM TI LOCKING SCREW W/T25; TFNA FENESTRATED SCREW
• Outcome Attributed to Adverse Event: Required Intervention