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	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight is unknown.Unknown date in (b)(6) 2018.Complainant part is not expected to be returned for manufacturer review/investigation, as it was reportedly discarded.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 the patient underwent a hardware removal of a trochanteric fixation nail -advanced (tfna) on (b)(6) 2018 due to migration of the tfna helical blade.Reportedly, the surgeon did not think the device failed but could possibly be related to the patient¿s poor bone quality.It is unknown if the patient had discomfort related to the device malfunction.The original surgery was performed on (b)(6) 2018 at which time the patient was implanted with a tfna nail, a tfna helical blade and two locking screws.The tfna nail, tfna helical blade and two locking screws were removed whole and intact and the patient was converted to a total hip prothesis.The procedure was successfully completed.There was no surgical delay reported.No harm was reported to the patient.The reported patient outcome was good.Concomitant devices reported: 12mm/130 deg ti cann tfna (part 04.037.259s, lot h423771, quantity 1); 5.0mm ti locking screw w/t25 (part 04.005.526s, lot h567843, quantity 1); 5.0mm ti locking screw w/t25 (part 04.005.530s, lot h601438, quantity 1).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.Patient ethnicity is unknown.Expiration date: this information is now known.Part: 04.038.285s; lot: h588102; date of manufacture: april 09, 2018; place of manufacture: elmira; part expiration date: february 28, 2028; 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.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 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: 7620088
• Report Number: 2939274-2018-52559
• Device Sequence Number: 1422644
• Product Code: HSB
• UDI-Device Identifier: 10886982098979
• UDI-Public: (01)10886982098979
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

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: 04.038.285S
• Device Catalogue Number: 04.038.285S
• Device Lot Number: H588102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 06/27/2018
• 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