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.Additional device product code is hwc.(b)(4).(b)(6).The subject device is not expected to be returned to the synthes manufacturer for evaluation.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 review was performed for the reported subject device lot.Manufacturing location: synthes (b)(4).Date of manufacture: jun 10, 2016.Expiration date: jun 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-conformances were generated during the production of the subject device.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 revision surgery with hardware removal was performed on (b)(6) 2017 due to blade migration and perforation of the femoral head.The patient was initially implanted with a proximal femoral nail antirotation ii (pfna-ii) system on (b)(6) 2016 to treat a trochanteric femoral fracture.On (b)(6) 2017, it was discovered that the pfna-ii blade had migrated and perforated the femoral head.On (b)(6) 2017, revision surgery was performed to reset the blade to the correct position.Please see related complaint, (b)(4), which addresses and reports the first revision surgery.During the second revision surgery on (b)(6) 2017, the blade was removed completely.Concomitant medical products: pfna-ii - prox.Fem.Nail (part# 472.105s lot# unknown / quantity 1); locking bolt ø 4.9mm, self-tapp (part# 459.340vs / lot# unknown / quantity 1); pfna-ii end cap (part# 473.170s / lot# unknown / 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: 6463834
• MDR Text Key: 71888242
• Report Number: 9612488-2017-10156
• 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
• Report Date: 03/14/2017

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: Health Professional
• Device Catalogue Number: 04.027.051S
• Device Lot Number: L009812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2017
• Initial Date FDA Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 459.340VS, LOCKING BOLT Ø 4.9MM, SELF-TAP, QTY 1; 472.105S, PFNA-II - PROX. FEM. NAIL, QTY 1; 473.170S , PFNA-II END CAP, QTY 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR