MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA-II BLADE L80 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.051S

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Perforation (2001); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(6).510(k): device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record (dhr) review was performed for the reported subject device lot.Manufacturing location: synthes (b)(4).Date of manufacture: dec 21, 2016.Expiration date: dec 1, 2026.The review showed that there were no issues during the manufacture of the product lot that would contribute to this complaint condition.No non-conformance reports (ncrs) were generated during the production of the subject device.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes europe reported an event in (b)(6) as follows: it was reported that the proximal femoral nail antirotation (pfna) blade cut out postoperatively.The pfna blade and nail were initially implanted on (b)(6) 2017 to treat a trochanteric femoral fracture.On (b)(6) 2017, it was discovered that the blade had cut out.The surgeon commented that the reason the blade cut out is that ¿he inserted the blade ahead¿ (too far) and that this was a technical error on his part.Revision surgery including total hip arthroplasy will be planned.Concomitant medical products: pfna nail, part: 472.101s, lot: l210177, quantity: 1.This report is 1 of 1 for (b)(4).

• Brand Name: PFNA-II BLADE L80 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: 6517606
• MDR Text Key: 73558008
• Report Number: 9612488-2017-10189
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.051S
• Device Lot Number: L237428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 472.101S, PFNA NAIL, QTY 1
• Patient Outcome(s): Required Intervention