MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 85MM STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.038.285S

Device Problem Use of Device Problem (1670)

Patient Problems Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part number: 04.038.285s, lot number: h433299, part manufacturing date: 11 september 2017, manufacturing site: (b)(4), part expiration date: 01 september 2027, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot: h433299 of tfna helical 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: h189259 met all specifications with no issues documented that would contribute to this complaint condition.(b)(4).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 on an unknown date, it was observed that a 2-3 mm of the trochanteric femoral nail advance (tfna) helical blade was protruded from the joint surface of the bone head.Initially, the tfna system was implanted on (b)(6) 2018.A revision surgery will be performed on an unknown schedule.According to the surgeon, there was no allegation against the blade because supposedly the blade was longer than the proper length.Patient outcome is unknown.This report is for one (1) tfna helical blade.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TFNA HELICAL BLADE 85MM STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8363630
• MDR Text Key: 136924123
• Report Number: 8030965-2019-61328
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• 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: H433299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR