MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA-II BLADE L85 TAN; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.027.052S

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Perforation (2001); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: date of event is unknown.(b)(4).Date of explant is unknown.The planned date of revision surgery is unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4).Device history records review was completed for part # 04.027.052s, lot # l082110.Manufacturing location: (b)(4), manufacturing date: aug 04, 2016, expiry date: jul 01, 2026.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product 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 follow: it was reported that on (b)(6) 2017, patient underwent a surgery for femur trochanteric fracture.During the surgery, the surgeon fixed the bone but he couldn¿t completely set the bone where it was supposed to be.Three weeks after surgery, the patient complained of femoral pain and the surgeon found the blade had been cut out.Patient was reportedly under observation and a revision surgery will be planned.Concomitant devices: pfna-ii ø10 xs 125° l170 tan (part # 472.101s, lot # 9576125, quantity 1).This report is for one (1) unknown cortex screw.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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

This report is for one (1) pfna blade.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Date received by manufacturer was reported as mar 24, 2016 in error in follow up medwatch# (b)(4).Correct date is mar 24, 2017.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

Device was used for treatment, not diagnosis.(b)(6).(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFNA-II BLADE L85 TAN
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6432890
• MDR Text Key: 70856921
• Report Number: 9612488-2017-10131
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup,Followup
• Report Date: 03/02/2017

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: Physician
• Device Catalogue Number: 04.027.052S
• Device Lot Number: L082110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/24/2017; 03/27/2017; 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PART # 472.101S, LOT # 9576125, QUANTITY 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR