MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 80MM STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.280S

Device Problem Migration (4003)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: unknown date in 2018.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient complained of continued pain after falling down at the hospital on (b)(6) 2018.The patient was then unable to walk after falling down again on (b)(6) 2018.Originally, the patient had an osteosynthesis using trochanteric femoral nail advanced (tfna) for femoral trochanteric fractures on (b)(6) 2018.On (b)(6) 2018, the surgeon assessed the patient, and it was confirmed that the helical blade had penetrated the acetabular roof.The latest x-ray images showed another fracture line other than the original fracture.Revision surgery was made on (b)(6) 2018.The procedure was completed successfully, and the tfna nail, helical blade, and screw were all removed.There was no surgical delay.Patient outcome was unknown.Concomitant devices reported: tfna femoral nail l170mm (part #: 04.037.012s, lot #: h540220, quantity: 1) and unknown tfna screw (part #: unknown, lot #: unknown, quantity: 1).This report is for one (1) tfna helical blade 80mm sterile.This is report 1 of 1 for (b)(4).

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.Device history lot : part number: 04.038.280s, lot number: h599719, part manufacturing date: 03 may 2018, manufacturing site: (b)(4), part expiration date: 01 april 2028, a review of the device history record revealed no complaint related anomalies.The device history record shows lot h599719 of tfna helical blades was processed through the normal manufacturing and inspection operations with no nonconformances noted.8 pieces from the lot were reworked to correct an uneven anodize finish; this rework was completed successfully, and the rework operations are not expected to have altered any mechanical or dimensional properties of the parts.This rework is therefore determined to have no relation to the complaint condition.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 h463275 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.

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.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 80MM STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8180665
• MDR Text Key: 130890553
• Report Number: 8030965-2018-59175
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652422
• UDI-Public: (01)07611819652422
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.280S
• Device Lot Number: H599719
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR