MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 105MM STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.305S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.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.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 an unknown date that the trochanteric fixation nail advanced (tfna) helical blade has impacted to the articular surface.It was mentioned that the fracture seems to be healed already before the reported issue occurred.It is unknown how the issue was discovered.It is unknown if there is a need for another surgery.Concomitant device reported: unknown tfna nail (part # unknown, lot # unknown, quantity 1), unknown end cap (part # unknown, lot # unknown, quantity 1), unknown locking screw (part # unknown, lot # unknown, quantity unknown).This report is for one (1) tfna helical blade 105 mm 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.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.Part number: 04.038.305s.Lot number: h395079.Part manufacturing date: 03 august 2017.Manufacturing site: elmira.Part expiration date: 30 june 2027.Nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h395079 of tfna helical blades was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot h189268 met all specifications with no issues documented that would contribute to this complaint condition.A review of the device history record revealed no complaint related anomalies.This lot met all dimensional and visual criteria at the time of manufacture 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: TFNA HELICAL BLADE 105MM 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: 9667915
• Report Number: 2939274-2020-00637
• Device Sequence Number: 2799851
• Product Code: HSB
• UDI-Device Identifier: 10886982099051
• UDI-Public: (01)10886982099051
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2020

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: 04.038.305S
• Device Catalogue Number: 04.038.305S
• Device Lot Number: H395079
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention