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

Catalog Number 04.038.280S

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient identifier and weight not available for reporting.Date of device migration is not known explant of device was scheduled for (b)(6) 2018.Removal has not been confirmed.Complainant part is not expected to be returned for manufacturer review/investigation.Dhr review was completed.Part number: 04.038.280s.Lot number: h286498.Part manufacturing date: 10 march 2017.Manufacturing site: (b)(4).Part expiration date: 01 march 2027.Nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h286498 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 9974143 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported patient underwent an open reduction internal fixation (orif) using the trochanteric fixation nail advanced (tfna) system for a jensen type 3 femoral trochanteric fracture on (b)(6) 2018.On (b)(6) 2018, it was confirmed that the tfna helical blade has cut out.Surgeon stated that the nail was inserted slightly posterior and that a longer nail should have been selected for implant.Patient is reported to visit the hospital on a regular basis.Patient is scheduled for return to surgery on (b)(6) 2018 for removal of the implants.Due to patient¿s age, revision to new hardware is not being considered at this time.It is not known if the removal procedure has taken place.Concomitant devices reported: 5.0mm locking screw with t25 stardrive 34mm for im nail (04.005.524s, lot l694446, quantity 1); 10mm 125 degree cannulated tfna nail 170mm (04.037.012s, lot h521782, quantity 1); end cap for tfna 0mm extension (04.038.000s, lot l590134, quantity 1).This report is for one (1) tfna helical blade 80mm.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.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

It was further reported that there is no prospect for healing of the bone in the future.

• 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: 7837069
• MDR Text Key: 118895826
• Report Number: 8030965-2018-56102
• 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
• Report Date: 08/13/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.280S
• Device Lot Number: H286498
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 08/31/2018
• Supplement Dates Manufacturer Received: 09/03/2018
• Supplement Dates FDA Received: 09/04/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 94 YR