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

Catalog Number 04.038.285S

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: event year is reported as 2021; however exact date of event is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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: product code #: (b)(4).Synthes lot #: h845712.Supplier lot #: n/a.Released to warehouse: (b)(6) 2019.Expiration date: (b)(6) 2029.Manufactured by: (b)(6).No ncrs were generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent osteosynthesis surgery for trochanteric fracture of femur.The reduction position became valgus, but it was fixed.The surgery was completed with no surgical delay.After the surgery, the patient was undergoing rehabilitation.Around april 2021, cut-out occurred.Tha surgery was recommended, and the surgery performed on (b)(6) 2021.During the surgery, the blade caused inappropriate sliding, and the fracture site became pseudarthrosis.The bone head was rotated and dislocated half a year later, resulting in cut-out.No further information is available.This complaint involves five (5) devices.This report is for (1) tfna helical blade 85mm sterile.This report is 2 of 4 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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: product code #: 04.038.285s.Synthes lot #: h845712.Supplier lot #: n/a.Released to warehouse: 18mar2019.Expiration date: 01mar2029.Manufactured by: elmira.No ncrs were generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent osteosynthesis surgery for trochanteric fracture of femur.The reduction position became valgus, but it was fixed.The surgery was completed with no surgical delay.After the surgery, the patient was undergoing rehabilitation.Around (b)(6) 2021, cut-out occurred.Tha surgery was recommended, and the surgery performed on (b)(6) 2021.During the surgery, the blade caused inappropriate sliding, and the fracture site became pseudarthrosis.The bone head was rotated and dislocated half a year later, resulting in cut-out.No further information is available.This complaint involves five (5) devices.This report is for (1) tfna helical blade 85mm sterile.This report is 2 of 4 for (b)(4).

• Brand Name: TFNA HELICAL BLADE 85MM STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13026360
• MDR Text Key: 286049948
• Report Number: 8030965-2021-10303
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652439
• UDI-Public: (01)07611819652439
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.285S
• Device Lot Number: H845712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE Ø3.2 L400.; LOCKSCR Ø5 L40 F/NAILS TAN LIGHT GREEN.; TFNA END CAP EXTENS. 0 TAN.; TFNA FEM NAIL Ø10 125° L170 TIMO15.
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 65 KG