MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI SPIRAL BLADE 90MM FOR TI RETROGRADE FEMORAL NAILS-EX; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.013.050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); No Code Available (3191)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(b)(4).Investigation summary: 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: 04.013.050, lot number: 6781134, part manufacturing date: 27 september 2011, manufacturing site: (b)(4), part expiration date: n/a, nonconformance noted: ncr # 1041955.A review of the device history record revealed no complaint related anomalies.The device history record shows lot 6781134 of ti spiral 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 6650254 was opened on ncr # 1041955.This nonconforming report was opened due to observed discoloration at the ends of some raw material bars.The nonconformance investigation determined that this condition had no negative impact on the material, as the ends of each bar are removed during processing without being incorporated into any parts.This nonconformance is determined not to have any relevance to the complaint condition.Device history review: 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.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient underwent a revision surgery due to chronic osteomyelitis, infection, inflammation, nonunion of joint, and delayed healing.One (1) hindfoot nail, one (1) spiral blade, one (1) 6mm unknown locking screw, and one (1) 5mm unknown locking screw were removed.All hardware was intact.After the removal, the extremity of the patient was i&d using ria.There was no surgical delay.  it is unknown if procedure was successfully completed.Patient status was good.This complaint involves four (4) devices.This is 4 of 4 for report (b)(4).

• Brand Name: TI SPIRAL BLADE 90MM FOR TI RETROGRADE FEMORAL NAILS-EX
• 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: 9342485
• Report Number: 2939274-2019-62278
• Device Sequence Number: 2721912
• Product Code: HSB
• UDI-Device Identifier: 10886982087546
• UDI-Public: (01)10886982087546
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.013.050
• Device Catalogue Number: 04.013.050
• Device Lot Number: 6781134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/19/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 93