MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 85MM STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.285S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date if event: unknown date in 2017.Implanted date: unknown date in (b)(6) 2017.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a removal of an intramedullary (im) trochanteric fixation nail advanced (tfna) due to helical blade cut-out on (b)(6) 2017.The original procedure was (b)(6) 2017.The patient is (b)(6) years old, and has poor bone quality.There was no reported fall or other trauma.Removed hardware included: nail, blade and locking screw; all were intact.The patient is in hospice an was non-ambulatory prior to the removal procedure, so no hardware revision was performed.The original fracture site collapsed on itself.The hardware was removed without incident.No sign of infection was present.The procedure was completed successfully with the patient in stable condition.Concomitant devices: tfna nail (part 04.037.142s, lot h310883, quantity 1); locking screw (part 04.005.528, lot unknown, quantity 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A device history record review was performed for the subject device: part number: 04.038.285s lot number: h159247, date of manufacture: 26 august 2016.Place of manufacture: (b)(4).Part expiration date: 31 july 2026.Nonconformance noted: n/a.Description of dhr review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 85mm sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.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 review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material 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.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.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 85MM 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: 7169478
• Report Number: 2939274-2018-50099
• Device Sequence Number: 11105648
• Product Code: HSB
• UDI-Device Identifier: 10886982098979
• UDI-Public: (01)10886982098979(17)260731(10)H159247
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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: 07/31/2026
• Device Model Number: 04.038.285S
• Device Catalogue Number: 04.038.285S
• Device Lot Number: H159247
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 41